| CTRI Number |
CTRI/2025/10/095622 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
04/10/2025 |
| 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
|
“Effect of special balance exercises on balance and tiredness in people with type 2 diabetes”
|
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Scientific Title of Study
|
Effect of sensorimotor training on balance and fatigue in patients with type 2 diabetes mellitus-Randomized control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhvani Lagdiwala |
| Designation |
PG student |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Parul Sevashram Hospital Neuro OPD Room No.201 Post Office Limda Taluka Waghodia District Vadodara 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9909848172 |
| Fax |
|
| Email |
lagdiwaladhvani0211@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Joyal Tejpal |
| Designation |
Assistant Professor |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Parul Institute of Physiotherapy Parul University Room no 409 Post office Limda Taluka Waghodia District Vadodara State Gujarat 391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
9909981454 |
| Fax |
|
| Email |
joyal.tejpal25384@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dhvani Lagdiwala |
| Designation |
PG student |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Parul Sevashram Hospital Neuro OPD Room No.201 Post Office Limda Taluka Waghodia District Vadodara 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9909848172 |
| Fax |
|
| Email |
lagdiwaladhvani0211@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Sevashram Hospital Neuro Opd Room no.201 Post Office Limda Taluka Waghodia District Vadodara 391760 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [] |
|
|
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 |
| Dhvani Lagdiwala |
Parul Sevashram Hospital |
Physiotherapy Department Neuro OPD Room No.201 Post Office Limda Taluka Waghodia District Vadodara 391760
Vadodara
GUJARAT |
9909848172
lagdiwaladhvani0211@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul University Institutional Ethics Committee for Human Research |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Group |
RELAXATION TECHNIQUE for 5 mins
Jacobson relaxation technique
Passive relaxation technique
BREATHING EXERCISE
Diaphragmatic breathing 3 to 4 reps
STRENGTH TRAINING
To the lower limb muscles quadriceps hamstring calf
Start with 10 reps and gradually increase weights
STRETCHING EXERCISE
Leg and back muscles hamstring quadriceps calf glutei upper back lower back for 30s hold 3 reps |
| Intervention |
SENSORI MOTOR TRAINING |
Sessions 3 times per week
Total Duration 6 weeks
Treatment duration approx 45 to 50 mins per session
EXERCISES
Warm up for 5 to 10 minutes including Free mobility exercises of upper limb and lower limb
Sensorimotor training
Patients will train through 3 stages static dynamic and
functional
Each exercise will repeat 3 to 5 times 2 sets during a session with providing
enough rest periods in between each set of exercise
1st and 2nd weeks First phase
Balance training & proprioceptive exercise
sit to stand
standing upright position for 30s on a firm surface than on a soft surface
Tandem stance for 30s
Single leg stance also with eyes closed for 10s on firm surface then on a soft surface
Functional training
Walking exercise on a firm surface then on a foam one
Heel to toe walking
Side stepping
3rd and 4th weeks second phase
Balance training & proprioceptive exercise
Half-step position for 10s
One leg balance for 10s
Forward stepping lunge
Functional training
Squatting exercise
Against a wall and away from wall
One leg squat
Dual task balance exercises like perform balance exercises while completing a cognitive task
such as counting backwards
5th and 6th weeks third phase
Balance training & proprioceptive exercise
T-band kicks exercise
Marching
Functional training
Balance exercise on wobble board
a Balance with two legs eyes open multidirectional then eyes closed
b Balance with one leg eyes open multidirectional then eyes closed
Balance exercises with visual distractions such as TV or a picture
COOL DOWN for 5 to 10 minutes
Included deep breathing abdominal breathing and mild stretching |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Willing to participate
Both males and females
Age group between 45 to 60 years
Having type 2 diabetes mellitus since 7 or greater than 7 years
Having Berg balance score more than 40
Having Fatigue severity score between 27 to 35 mild fatigue |
|
| ExclusionCriteria |
| Details |
Patients with any neurological cardiovascular complication like MI
Any major vascular complication severe retinopathy severe nephropathy
Severe musculoskeletal impairment or recent surgery to LL
Patients with diabetic complications like diabetic foot Plantar ulceration
Had partial or total amputation of lower limb |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| berg balance scale |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fatigue severity scale |
6 weeks |
| Visual analogue fatigue scale |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
27/10/2025 |
| 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="6"
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
|
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Brief Summary
|
Background Type 2 Diabetes Mellitus is a widespread metabolic disorder characterized by chronic hyperglycemia and associated with complications such as impaired balance and increased fatigue. These issues reduce mobility, independence, and quality of life, especially in older and obese individuals. Sensorimotor training is a therapeutic approach that enhances proprioception, balance, coordination, and postural stability by targeting neuromuscular control. It may also improve muscle strength, flexibility, and endurance, helping reduce fatigue. This study uses the Berg Balance Scale to measure balance, the Fatigue Severity Scale, and the Visual Analogue Scale to assess fatigue levels in Type 2 Diabetes mellitus individuals.
Purpose of the Study The purpose of this study is to investigate the effectiveness of Sensorimotor Training in improving balance and reducing fatigue in individuals with Type 2 Diabetes Mellitus. While conventional exercise programs have shown benefits in diabetes management, the specific impact of sensorimotor on postural control and fatigue remains underexplored. This study aims to determine whether Sensorimotor training can serve as an effective, low-cost, and non-invasive intervention to enhance functional capacity and reduce fall risk. By using validated tools like the Berg Balance Scale,Fatigue Severity Scale, and Visual Analogue Scale, the study seeks measurable outcomes to support Sensorimotor’s clinical relevance.
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