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CTRI Number  CTRI/2024/04/064990 [Registered on: 01/04/2024] Trial Registered Prospectively
Last Modified On: 27/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Crossover Trial 
Public Title of Study   To improve balance and quality of life in elderly stroke patient to see the effect of balance exercises along with rhythmic stabilization technique. 
Scientific Title of Study   Effect of otago exercise program along with rhythmic stabilization technique to improve fall efficacy balance and quality of life in elderly stroke patient  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  VAISHNAVI WANKHEDE 
Designation  Post graduation Student 
Affiliation  Neuro Physiotherapy Department 
Address  Neuro Physiotherapy Department Dr. APJ Abdul kalam college of Physiotherapy Pravara institute of Medical Sciences.
Neuro Physiotherapy Department Dr. APJ Abdul kalam college of Physiotherapy Pravara institute of Medical Sciences.
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  7264967787  
Fax    
Email  wankhedevaishnavi06@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr komal Thorat 
Designation  Associate Professor, Neuro Physiotherapy Department 
Affiliation  Pravara Institute of Medical Sciences 
Address  Neuro Physiotherapy Department Dr. APJ Abdul Kalam College Of Physiotherapy, Pravara institute of Medical Sciences Loni Ahmednagar 413736
Neuro Physiotherapy Department Dr. APJ Abdul Kalam College Of Physiotherapy Pravara institute of Medical Sciences Loni Ahmednagar 413736
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  7558744584  
Fax    
Email  komal.physio@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  VAISHNAVI WANKHEDE 
Designation  Post graduation Student 
Affiliation  Pravara institute of medical science 
Address  Neuro Physiotherapy Department, Dr. APJ Abdul Kalam College of Physiotherapy Pravara institute of Medical Sciences Loni Ahmednagar 413736
Neuro Physiotherapy Department Dr. APJ Abdul Kalam College of Physiotherapy Pravara institute of Medical Sciences Loni Ahmednagar 413736
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  07264967787  
Fax    
Email  wankhedevaishnavi06@gmail.com  
 
Source of Monetary or Material Support  
Dr APJ Abdul kalam college of Physiotherapy Pravara institute of medical sciences 
Neuro Physiotherapy Deaprtment, Dr. APJ Abdul Kalam College Of Physiotherapy, Pravara institute of Medical Sciences, Loni, Ahmednagar, 413736 
 
Primary Sponsor  
Name  Dr APJ Abdul kalam college of Physiotherapy Pravara institute of medical sciences 
Address  Neuro Physiotherapy Department, Dr APJ AK College of Physiotherapy Pravara institute of medical sciences loni ahemednagar 413736 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Vaishnavi Deepak Wankhede  Pravara Rural Hospital  Department of Neurophysiotherapy Ahmednagar MAHARASHTRA
Ahmadnagar
MAHARASHTRA 		 7264967787

wankhedevaishnavi06@gmail.com 
Vaishnavi Deepak Wankhede  Pravara Rural Hospital  304 Neuro Physiotherapy Department, Dr APJ AK College of Physiotherapy
Ahmadnagar
MAHARASHTRA 		 7264967787

wankhedevaishnavi06@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Dr. APJAK COPT  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G938||Other specified disorders of brain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Effect of Otago exercise programme along with rhythmic stabilization technique to improve fall efficacy, balance and quality of life in elderly stroke patient : A randomized controlled trial  Group ‘A’ (Otago exercise with rhythmic stabilization + conventional neuro-rehabilitation) Otago exercise programme Exercises OEP starts with head movements, neck movements, back extension and trunk movements. For muscle strengthening with help of weight cuff are- Knee strengthening Hip strengthening Calf raises Toe raises For balance include-  Knee bend Backward walking Walk and turn around Sideways walk Heel to toe stand Heel toe walk Sit to stand Stair climbing For balance include-  Knee bend Backward walking Walk and turn around Sideways walk Heel to toe stand Heel toe walk Sit to stand Stair climbing 10 repetitions 2set 2)Trunk PNF patterns with rhythmic stabilization technique : Is an Alternating isometric contractions against resistance, no motion intended. TECHNIQUE: Rhythmic Stabilization for improving strength, stability and balance. It requires patient concentration and may be easier in a closed muscle chain. agonist and antagonistic activity together occurs resulting in possible co-contraction and Patient is able to control both directions. 1)Trunk rotation Patient position- is sitting position for increasing core strength and trunk stability. For stabilization- isometrics contraction of agonist and antagonist at the same time. Hand placement- one hand at the anterior shoulder and other hand is just below the inferior angle of scapula. Therefore, by normal breathing ask the patient to twisting to opposite direction and relax. Duration- 8-10 repetitions in 1 set 2)Upper trunk PNF ( lifting pattern) Patient position is in sitting or lying position. Procedure- left hand will be in extended, abducted and internally rotated position and with other hand will put it on the dorsal surface of left hand and head and trunk both will be flexed and rotated towards the right side and then ask the patient to lift the hand and then it reversing all movements. ie hand is externally rotated, flexed, abducted and head and trunk are extended and rotated towards the left. Duration- 8-10 repetitions in 1set (Reverse lifting pattern) In these all the movements are reverse so it is reverse lifting pattern.  
Comparator Agent  Effect of Otago exercise programme along with rhythmic stabilization technique to improve fall efficacy, balance and quality of life in elderly stroke patient : A randomized controlled trial  Group ‘B’ (Conventional neuro-rehabilitation therapy) Exercises Repetitions Frequency Conventional neurorehabilitation therapy include- Active assisted range of motion for upper limb and lower limb then progression to Active range of motion for upper limb and lower limb. Functional mobility include- Half squat Full squat Lunges SLR Balance training include- One leg standing Tandem standing Standing up and sitting down Walking while alternating knee lift with each step.. Weight shifting Trunk rotation Pertubation based balance training. 30 mins 5 times a week 4 times a week 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Age 45-70 years and older.
2.Able to understand instructions.
3.Both genders.
4.MMSE score ≥ 24.
5.Participants willing to participate
6.Ability to stand for at least a minute without any assistance on a stable surface 
 
ExclusionCriteria 
Details  1 Presence of psychiatric or other neurological disorders.
2. Patient who are on any medication to alter cognition.
3. Patients who are not willing to participate.
4. Medically unstable patients.
5. Un-cooperative patients 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Berg balance scale
2. Fall efficacy scale
3.Eq-5D Scale 		 Week 0 and Week 4 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   30/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Introduction
Stroke is a clinical syndrome marked by the sudden onset of localized neurological indications that persist longer than 24 hours or result in death, and is thought to be caused by a vascular problem. This definition includes stroke both due to infarction and due to haemorrhage. Among the leading causes of adult disability worldwide and a major global health issue, stroke ranks as the second or third most prevalent cause of death.1 It can be caused by a number of different pathologies which all result in a usually sudden-onset focal cerebral damage. 1The majority of strokes are caused by intracerebral bleeding, with a small percentage caused by subarachnoid haemorrhage.2 The remaining 80% are due to ischemic stroke which itself has a number of different subtypes, including large artery disease, cardio embolism, and small vessel disease.1 Stroke patients have a two-fold higher risk of falling than other people with same age or gender. In particular 30% to 50% of elderly those over 65 years old experience falls every year.3 Loss of independent community ambulation is one of the most disabling consequences of stroke.4 According to a recent meta-analysis, women with stroke were 30% less likely than males to get tissue plasminogen activator, and some studies have shown that they experienced longer in-hospital delays. After a stroke, more than 85% of these people develop hemiplegia right away.5 

There are two types of hemiplegia: acquired and congenital. It is known as acquired hemiplegia when it develops later in life as a result of an injury or disease. Congenital hemiplegia occurs prior to, during, or shortly after birth (up to two years of age, roughly).6 The most common risk factor is age, which is the biggest predictor of both primary intracerebral hemorrhage and cerebral infarction. (For example, the risk of stroke is more by 25 times in people aged 75–84 years then the risk in people aged 45–54.). 7Gender - Male gender is a risk factor for stroke, however because of their longer life expectancy and the relevance of age as a risk factor, more men die from stroke than women.8 Blood pressure - Increasing blood pressure is a major risk factor for stroke and is strongly and independently associated with both ischemic and haemorrhagic strokes. Smoking - Cigarette smoking people are more prone to develop the risk of stroke.9 Carbon monoxide and nicotine enter the bloodstream when you inhale cigarette smoke. Nicotine makes the heart beat quicker and increase blood pressure, while carbon monoxide reduces the amount of oxygen content in blood giving rise to stroke.10Diabetes mellitus– Diabetes is also a risk factor of stroke. It is said to be a risk factor for both carotid atherosclerosis as well as large vessel disease. Body mass index and physical exercises–Increase in body mass index is a risk factor for stroke although it is partly because of its association with other risk factors such as hypertension and diabetes.11 Other risk factors for stroke include migraine, especially migraine with aura, and the oral contraceptive pill (especially oestrogen containing versions). Hormone replacement therapy appears to increase the risk of stroke, particularly soon after its initiation.12 Balance disorders in patients with stroke cause restrictions in daily living activities, which in turn reduces their independence and their level of participation in community. Since most patients with stroke will survive the initial illness, the greatest health effect is usually caused by long term consequences for patients and their families.13Over the next two decades, the prevalence of strokerelated burden is predicted to rise. Promising interventions that could be beneficial to improve the aspects of gait include fitness training, high intensity therapy and repetitive task Physiotherapy is established component of stroke rehabilitation but uncertainties remain about the most appropriate intensity of therapy input.14 10 Physiotherapy in the rehabilitation of stroke patients is represented by various approaches, e.g. Proprioceptive Neuromuscular Facilitation, Brunnstrøm, Bobath and the Motor Relearning Programme.15 The Bobath concept represents a theoretical framework in a reflex-hierarchical theory, while Motor Relearning Programme is based in system theory, and is basically task oriented. During walking, stroke patients usually exhibit imbalance and compensatory movements in different parts of their body, experience trouble with everyday activities, and may sustain injuries from falls. The ability of stroke patients to walk has been examined with a variety of approaches, including virtual reality, robotics, and mental exercise using motor imagery.16 Otago Medical School established the Otago exercise program (OEP). OEP is a physical therapist-created, evidence-based fall prevention program that is meant to be used at home.17 The Otago Exercise Program (OEP) is among the newest plans for at-home exercise training. In New Zealand, the OEP was initially implemented. OEP is divided into three areas: walking, balance training, and muscle strengthening. The measures used to avoid falls in the elderly are called Otago exercises. OEP is a muscle strengthening and balance retraining program.3 The Otago exercise program (OEP) is one of the most recent home-base exercise training programs.18 Otago Exercise Program is a strength & balance retraining program designed to prevent falls in older people  and studies have proved that this structured exercise program has improved the elderly patient’s balance, lower limb strength, general fitness level, reduced the fear of fall and has improved their independency level.19“Rhythmic Stabilization” technique utilizes alternating isometric contractions against resistance.20 This technique is useful in maintaining a co-contraction of antagonistic muscles against maximal resistance which builds up excitation and further helps to increase active and passive range of motion, strength, stability, and balance, as well as to control pain.21

There are various intervention techniques to improve gait, balance and sit to stand performances. From which Rhythmic Stabilization is an effective intervention to improve gait, balance and sit to stand disabilities. Therefore, this study aims to find out the most effective intervention for stroke patients.22 

 NEED FOR THE STUDY

 Balance problem is considered as a serious complication in rehabilitation of stroke patient. Stroke patient have fall risk due to imbalance particularly elderly patient have fracture risk due to osteoporosis and degeneration. Several techniques are utilized to prevent imbalance in stroke patient especially strength training programme are designed to prevent fall risk in elderly but Otago exercise programme is well researched program to reduce fall among older people and also trunk PNF with rhythmic stabilization technique it also helps to improving in strength, stability and balance. Hence, need of my study is to check the efficacy of Otago exercise programme along with rhythmic stabilization to improve fall efficacy, balance and quality of life in elderly stroke patient.

 

RESEARCH QUESTION

 

Will there be any effect of Otago exercise along with rhythmic stabilization to improve fall efficacy,balance and quality of life in elderly stroke patient?.

 

AIM AND OBJECTIVES

Aim:

The aim of the study is to investigate the effect of OTAGO exercise program along with rhythmic stabilization exercise to improve fall efficacy scale, balance and quality of life in elderly stroke patient.

 

Objective:

1. To find out the effectiveness of Otago exercise with rhythmic stabilization exercise to improve  balance using Berg balance scale .

2. To find out the effiectiveness of Otago exercise with rhythmic stabilization exercise to improve fall prevention by using fall efficacy scale.

3. To find out the effectiveness of Otago exercise with rhythmic stabilization exercise to improve functional performance using time up and go test (TUG).

4. EQ-5D for quality of life in stroke patient.

 

Hypotheses

 

Null Hypothesis (H0):

There will be no significant effect of the Otago exercise program along with rhythmic stabilization exercise to improve fall efficacy scale, balance and quality of life in elderly stroke patients.

 

Alternative Hypothesis (H1): 

There will be significant effect of the Otago exercise program along with rhythmic stabilization exercise to improve fall efficacy scale, balance and quality of life in elderly stroke patients.


 MATERIAL AND METHODOLOGY

Study Setting- In-Patient Department of Medicine and Out–patient Department of Neuro Physiotherapy at Dr. APJAK College of Physiotherapy,PIMS,LONI.

Study Design: Randomized controlled trial

Study Duration: 2 years

Sampling Method: Simple Random Sampling.

Sample size: 36


OUTCOME MEASURES

Outcome measures used for this study will be as follows

1. Balance (berg balance scale) ( reliability of 0.98)

2. Fall prevention (fall efficacy scale) ( reliability of  0.94)

3. Quality of life (EQ-5D Scale)( reliability of 0.90)



SELECTION CRITERIA:

 

Inclusion criteria:

Participants included will be:

 

1. Age 45-70 years and older.

2. Able to understand instructions.

3. Both genders.

4. MMSE score ≥ 24.

5. Participants willing to participate

6. Ability to stand for at least a minute without any assistance on a stable surface

Exclusion criteria:

Participants excluded will be:

1. Presence of psychiatric or other neurological disorders.

2.  Patient who are on any medication to alter cognition.

3. Patients who are not willing to participate.

4. Medically unstable patients.

5. Un-cooperative patients


PROCEDURE

Group ‘A’ (Otago exercise with rhythmic stabilization + conventional neuro-rehabilitation)

1) Otago exercise programme

EXERCISES

REPETITIONS

FREQUENCY

OEP starts with head movements, neck movements, back extension and trunk movements.

 

10 repetitions 2 set

 

 

 

 

 

 

 

     

 

 

 

 

 

 

 

 

4 times a week/ 45 min session

For muscle strengthening with help of weight cuff are-

Knee strengthening

Hip strengthening

Calf raises

Toe raises

 

 

10 repetitions 2 set

 

For balance include-

Knee bend

Backward walking

Walk and turn around

Sideways walk

Heel to toe stand

Heel toe walk

Sit to stand

Stair climbing

 

 

 

 

 

 

 

10 repetitions 2set


1) Trunk PNF patterns with  rhythmic stabilization technique :

Is an Alternating isometric contractions against resistance, no motion intended.

 

TECHNIQUE:

Rhythmic Stabilization for improving strength, stability and balance. It requires patient concentration and may be easier in a closed muscle chain. agonist and antagonistic activity together  occurs resulting in possible co-contraction and Patient is  able to control both directions.

 

1) Trunk rotation

Patient position-  is sitting position for increasing core strength and trunk stability.

For stabilization- isometrics contraction of agonist and antagonist at the same time.

Hand placement- one hand at the anterior shoulder and other hand is just below the inferior angle of scapula.

Therefore, by normal breathing ask the patient to twisting to opposite direction and relax.

Duration- 8-10 repetitions in 1 set

 

2) Upper trunk PNF ( lifting pattern)

 

Patient position is in sitting or lying position.

Procedure- left hand will be in extended, abducted and internally rotated position and with other hand will put it on the dorsal surface of left hand and head and trunk both will be flexed and rotated towards the right side and then ask the patient to lift the hand and then it reversing all movements. ie hand is externally rotated, flexed, abducted and head and trunk are extended and rotated towards the left.

Duration- 8-10 repetitions in 1set

 

(Reverse lifting pattern)

 In these all the movements are reverse so it is reverse lifting pattern.

Group ‘B’ (Conventional neuro-rehabilitation therapy)

EXERCISES

REPETITIONS

FREQUENCY

 

Conventional neurorehabilitation therapy include-

Active assisted range of motion for upper limb and lower limb then progression to Active range of motion for upper limb and lower limb.

Functional mobility include-

Half squat

Full squat

Lunges

SLR

Balance training include-

One leg standing

Tandem standing

Standing up and sitting down

Walking while alternating knee lift with each step..

Weight shifting

Trunk rotation

Pertubation based balance training.

 

 

 

 

 

 

 

 

 

 

 

 

30 mins 5 times a week

 

 

 

 

 

 

 

 

 

 

 

4 times a week


REFERENCES

 

1.  Kim K, Jung SI, Lee DK. Effects of taskoriented circuit training on balance and gait ability in subacute stroke patients: a randomized controlled trial. Journal of physical therapy science. 2017;29(6):989- 92.

2.  Sebin Jose, K Sangita. Effectiveness of Otago Exercise to Improve Balance, Quality of Life and to Reduce Risk of Fall in Hemiplegic Patients International Journal of Science and Research (IJSR) ISSN: 2319-7064 Research Gate Impact Factor (2018): 0.28 | SJIF (2018): 7.426.

3.  Yang YR, Wang RY, Lin KH, Chu MY, Chan RC. Task-oriented progressive resistance strength training improves muscle strength and functional performance in individuals with stroke. Clinical rehabilitation. 2006PMID: 12431229.

4. Park Y, Chang M. Effects of the Otago exercise program on fall efficacy, activities of daily living and quality of life in elderly stroke patients. Journal of physical therapy science. 2016;28(1):190- 3.

5. Downs S, Marquez J, Chiarelli P. The Berg Balance Scale has high intra-and inter-rater reliability but absolute reliability varies across the scale: a systematic review. Journal of physiotherapy. 2013 Jun 1;59(2):93-9.

6. Balance training following stroke: effects of taskoriented exercises with and without altered sensory input Jean-Franc¸ ois Bayouka , Jean P. Bouchera and Alain Lerouxb, International Journal of Rehabilitation Research 29:51–59.

7. Task-related circuit training improves performance of locomotor tasks in chronic stroke: a randomized, controlled pilot trial. Arch Phys Med Rehabil 81:409– 417. Di Fabio RP, Badke MB (1990).

8. Otago Medical School: Otago exercise programme to prevent falls in older adults. Otago: University of Otago, 2003.

9. Kristensen MT, Foss NB, Kehlet H. Timed "Up and Go" Test as a predictor of falls within 6 months after hip fracture surgery. Phys Ther. 2007.87(1):24-30.

10. Bohannon RW. Reference values for the Timed Up and Go Test: A Descriptive Meta-Analysis. Journal of Geriatric Physical Therapy, 2006;29(2):64-8.

11. Liu-Ambrose T, Donaldson MG, Ahamed Y, et al.: Otago home-based strength and balance retraining improves executive functioning in older fallers: a randomized controlled trial.

12. Yoo HN, Chung E, Lee BH: The effects of augmented reality-based Otago exercise on balance, gait, and falls efficacy of elderly women. J Phys Ther Sci, 2013, 25: 797–801.

13. Davis JC, Marra CA, Najafzadeh M, et al.: The independent contribution of executive functions to health related quality of life in older women. BMC Geriatr, 2010, 10:

14. Jørgensen L, Engstad T, Jacobsen BK: Higher incidence of falls in long-term stroke survivors than in population controls: depressive symptoms predict falls after stroke,2002,33:

15. World Health Organization: WHO global report on falls prevention in older age. Geneva: World Health Organization, 2007

16. Fagerström C, Borglin G: Mobility, functional ability and health-related quality of life among people of 60 years or older. Aging Clin Exp Res, 2010, 22: 

17. Relationship of sensory organization to balance function in patients with hemiplegia. phys Ther 70:542–548.

18. Cheng PT, Wu SH, Liaw MY, Wong AM, Tang FT (2001). Symmetrical bodyweight distribution training in stroke patients and its effect on fall prevention. Arch Phys Med Rehabil 82:1650–1654. Dean CM, Richards CL, Malouin F (2000).

19. 5 Balance training following stroke: effects of taskoriented exercises with and without altered sensory input Jean-Franc¸ ois Bayouka , Jean P. Bouchera and Alain Lerouxb, International Journal of Rehabilitation Research 29:51–59 c 2006 Lippincott Williams & Wilkins. International Journal of Rehabilitation Research 2006, 29:51–59

20. Cho HY, Kim JS, Lee GC. Effects of motor imagery training on balance and gait abilities in post-stroke patients: a randomized controlled trial. Clinical rehabilitation. 2013 Aug;27(8):

21. Lisabeth LD, Brown DL, Hughes R, Majersik JJ, Morgenstern LB. Acute stroke symptoms: comparing women and men. Stroke. 2009 Jun 1;40(6):

22. Downs S, Marquez J, Chiarelli P. The Berg Balance Scale has high intra-and inter-rater reliability but absolute reliability varies across the scale: a systematic review. Journal of physiotherapy. 2013 Jun 1;59(2):93-9

23.pnf in practice: susan s. Adler dominiek Beckers math buck: third edition.

 
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