| CTRI Number |
CTRI/2024/02/062762 [Registered on: 16/02/2024] Trial Registered Prospectively |
| Last Modified On: |
09/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
How Treadmill Exercises Help After a Stroke
|
|
Scientific Title of Study
|
Effect of treadmill based gait training along with balance training on balance, gait and functional mobility among stroke patients. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vanshika kalia |
| Designation |
PG student |
| Affiliation |
Amity Institute of Health and Allied Sciences |
| Address |
lower ground floor, F1 block, department of physiotherapy, Amity Institute of Health and Allied sciences, Amity University, Sector 125, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
8826312577 |
| Fax |
|
| Email |
Vanshikakalia19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankit Jain |
| Designation |
Assistant Professor |
| Affiliation |
Amity Institute of Health and Allied Sciences, Amity University |
| Address |
F1 Block, Department of Physiotherapy, Amity Institute of Health and Allied Sciences, Amity University, Sector 125 Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9999600611 |
| Fax |
|
| Email |
ajain@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankit Jain |
| Designation |
Assistant Professor |
| Affiliation |
Amity Institute of Health and Allied Sciences, Amity University |
| Address |
F1 Block, Department of Physiotherapy, Amity Institute of Health and Allied Sciences, Amity University, Sector 125 Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9999600611 |
| Fax |
|
| Email |
ajain@amity.edu |
|
|
Source of Monetary or Material Support
|
| Amity OPD, Amity University, Gate no. 1, Noida, Sector 125, Uttar Pradesh, 201313 |
| Shop No. 5, Hans Plaza, R.K. Puram, Sadarpur Road, Ghaziabad, 201002 |
|
|
Primary Sponsor
|
| Name |
Vanshika Kalia |
| Address |
lower ground floor, F1 block, department of physiotherapy, Amity Institute of Health and Allied sciences, Amity University, Sector 125, Noida, Uttar Pradesh |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ankit Jain |
Amity OPD |
Amity OPD, Amity University, Gate no. 1, Noida, Sector 125, Uttar Pradesh, 201313
Gautam Buddha Nagar
UTTAR PRADESH |
9999600611
ajain@amity.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional NTCC committee, Amity Institute Of Health and Allied Sciences, Amity University, Uttar Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I630||Cerebral infarction due to thrombosis of precerebral arteries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1) over ground walking
2) Balance Training |
1) Over ground walking:
Exercises Duration
Short walk (50meters)
Walk on different slopes(inclination/declination) 50 steps
Obstacle avoidance 3 meters
Walk on visual cues 3 meters
Change in C.O.G (picking up an object from the floor) 3 meters
Walk in different directions 2 minutes
Heel strike (limb load acceptance) 10 repetitions
Initial swing of moving leg (push off) 10 repetitions
Stairs climbing 10 stairs
Walk in a straight line 3 meters
2) Balance training:
it is same for both the groups.
|
| Intervention |
1) Treadmill based gait training
2) Balance Training |
1)• Treadmill walking for 30 minutes 3 sessions per week for 6 weeks.
- Treadmill walking with patient tied up with yellow resisted band and push towards affected side.
- 30 minutes gait training with rest periods given in between.
- First we tied up theraband at hip abductors of affected side and push towards non affected side and patient is asked to walk.
- Secondly we tied up yellow theraband as the level of ASIS and push in anterior to posterior direction at an angle of 45o and then patient is asked to walk.
2) Balance training:
PHYSIO BALL
DESCRIPTION
DURATION
SUPINE LYING
1) PELVIC BRIDGING
In supine position both the patient’s legs placed on a gym ball and patient is asked to lift the pelvis off the support surface. Initially the ball positioned beneath the knees and advanced to the lower leg.
10 repetitions with 5 seconds hold
2) UNILATERAL BRIDGING
lifting the unaffected leg off
the ball while maintaining the same pelvic bridge position.
10 repetitions with 5 seconds hold
3) TRUNK ROTATION
Patient is asked to place both his legs on the gym ball and asked to move the ball to both the left and the right by rotating the pelvis. Initially the ball placed beneath the knees and then advanced towards the ankles.
10 repetitions for both sides
SITTING POSITION
1) STATIC SITTING
patient asked to sit on the gym ball with hips and knee both bent at 90 degrees and the feet keeps flat on the support surface.
2 minutes
2) TRUNK FLEXION/EXTENSION
Patient actively flexes and extends the trunk without moving the trunk backwards or forwards.
10 repetitions
3) UPPER TRUNK LATERAL FLEXION
Movement initiation from the shoulder girdle so as to bring the elbow towards the ball.
10 repetitions
4) LOWER TRUNK LATERAL FLEXION
Movement initiation from the pelvic girdle so as to lift the pelvis off the ball and bring it towards the ribcage.
10 repetitions
5) FORWARD REACH EXERCISE Patient is asked to reach at a fixed point at shoulder height by forward flexing the trunk at the hips. 10 repetitions
6) LATERAL REACH EXERCISE the patient is asked to reach out for a fixed point at shoulder height so as to elongate the trunk on the weight-bearing side and shorten the trunk on the non-weight-bearing side 10 repetitions
- Normal balance training on the ground.
EXERCISES
DURATION
1) Standing with both shoulder and legs with knee 200 flexed
20 repetitions
2) Standing on involved leg (50%) weight on the same
20 repetitions with 10 seconds hold
3) Patient is asked to put his unaffected leg on chair or stool.
20 repetitions
4) Slowly sit on the chair and get up from that chair
20 repetitions
5) Weight transfer on involved side
20 repetitions
• Balance training is also given 3 sessions per week for 6 weeks.
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosis of Stroke: Participants must have a documented history of a stroke, confirmed by medical records and diagnostic imaging.
2.Age Range: Participants aged between 40-60 years will be included to ensure a representative sample of stroke survivors within a manageable age range.
3.Time Since Stroke: Individuals who have experienced a stroke within the past 1 months to 2years will be eligible for inclusion, capturing a range of subacute to chronic stages of stroke recovery.
4.Ability to Ambulate: Individuals capable of walking with or without assistance, including assistive devices, will be considered for inclusion.
5.Cognitive Ability: Participants should possess sufficient cognitive ability to understand and follow instructions related to the rehabilitation program.
6. Willingness to participate: individuals who express a willingness and commitment to participate in the study.
7. Informed consent: individuals who provide informed written consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
1.Unstable Medical Condition: Individuals with unstable medical conditions, such as uncontrolled hypertension, recent cardiac events, or severe respiratory disorders, will be excluded due to potential risks associated with physical exertion.
2.Severe Cognitive Impairment: Participants with severe cognitive impairments, as determined by standardized cognitive assessments, will be excluded, as they may not be able to actively engage in and benefit from the rehabilitation program.
3.Non-ambulatory Individuals: Individuals who are completely non-ambulatory and unable to walk, even with assistance, will be excluded from the study.
4.Language Barriers: Individuals who do not understand or speak the language of instruction used in the rehabilitation program and assessments will be excluded.
5.Unwillingness to Participate: Individuals unwilling or unable to provide informed consent, commit to the rehabilitation program, or attend scheduled sessions will be excluded.
6.Pregnancy: Pregnant individuals will be excluded due to potential risks associated with physical exertion and the intervention.
7.Uncontrolled Pain: Participants experiencing uncontrolled pain that could hinder their participation in the rehabilitation program will be excluded.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| BERG BALANCE SCALE, TIME UP AND GO TEST, DYNAMIC GAIT INDEX AND MoCA SCALE. |
BERG BALANCE SCALE- Baseline, 3rd week, 6th week.
TIME UP AND GO TEST- Baseline, 3rd Week, 6th week.
DYNAMIC GAIT INDEX- Baseline, 3rd week, 6th week.
MoCA SCALE- Baseline, 3rd week, 6th week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/02/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This research endeavors to investigate the impact of treadmill based gait training along with balance training on balance, gait and functional mobility hence, improve functional independence and quality of life for stroke survivors. Through a meticulous selection process, a sample size of 68 participants is included in the study, with the clear criteria for inclusion and exclusion. The experimental design involves two distinct groups: Group 1, designated as a intervention group and Group 2: designated as control group. Group 1 undergoes targeted treadmill based gait training along with balance training, while Group 2 undergoes targeted over ground walking along with balance training. This comparative approach facilitates as in-depth analysis, assessing impact of these intervention on the primary outcomes in context of stroke recovery. The ultimate goal is to generate findings that can inform evidence-based practice protocols, guiding healthcare practitioners in the development of more effective and tailored interventions for individuals who have experienced a stroke. The study emphasis on rigorous participant selection ensures a focused and meaningful contribution to the broader field of stroke rehabilitation. |