| CTRI Number |
CTRI/2026/04/109053 [Registered on: 22/04/2026] Trial Registered Prospectively |
| Last Modified On: |
21/04/2026 |
| 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
|
The study is to compare balance exercises and strengthening exercises to improve quality of life balance issues and function in old aged patients with diabetic nerve damage. |
|
Scientific Title of Study
|
To compare the effectiveness of proprioceptive training versus strengthening exercises to improve balance, functional mobility and quality of life in diabetic neuropathy patients. |
| Trial Acronym |
not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kiran Jallewar |
| Designation |
Post graduate |
| Affiliation |
Malla reddy university |
| Address |
Department of physiotherapy, School of allied health and sciences, malla reddy university maisammaguda, bhadurpally hyderbad
500055
india
Hyderabad
TELANGANA
500055
India |
| Phone |
7385119198 |
| Fax |
|
| Email |
kiranjallewar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Janapathi Havilah |
| Designation |
Associate professor, MPT, Paediatrics |
| Affiliation |
Malla reddy university |
| Address |
School of health sciences department of physiotherapy malla reddy university maisammaguda bhadurpally hyderbad
School of health sciences department of physiotherapy malla reddy university maisammaguda bhadurpally hyderbad
Hyderabad
TELANGANA
500100
India |
| Phone |
7780117434 |
| Fax |
|
| Email |
drjanapati.havilah@mallareddyuniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Kiran Jallewar |
| Designation |
Post graduate student |
| Affiliation |
Malla reddy university |
| Address |
Department of physiotherapy, school of allied health and sciences malla reddy university maisammaguda bhadurpally hyderbad
Department of physiotherapy, school of allied health and sciences malla reddy university maisammaguda bhadurpally hyderbad
Hyderabad
TELANGANA
500055
India |
| Phone |
7385119198 |
| Fax |
|
| Email |
kiranjallewar@gmail.com |
|
|
Source of Monetary or Material Support
|
| school of allied health and sciences Department of physiotherapy malla reddy university ,maisammaguda ,hyderabad 500055
India |
|
|
Primary Sponsor
|
| Name |
malla reddy university |
| Address |
department of physiotherapy,school of allied health and sciencesmalla reddy university maisammaguda bhadurpally hyderbad 500055 India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Kiran jallewar |
Malla reddy university |
Department of physiotherapy, school of allied health and sciences maisammaguda hyderabad 500055, India
Hyderabad
TELANGANA |
7385119198
kiranjallewar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE MRIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
proprioceptive training
participants received Proprioceptive training exercises thrice a week for eight weeks
Proprioceptive training exercises included one leg balance, heel walking, cross-body leg swings, and partial squat in sitting Each exercise will performed for ten minutes under supervision, five sets of each exercise with a rest of one minute between each exercise The total duration was of fifty minutes including five minutes of warm-up sessions lower limb stretching
|
one leg balance heel walking and cross leg body swing
One leg balance test It involved standing on affected foot, and the other leg raised to the back at ninety degree This position held for 10 to 20 seconds After a brief rest three similar repetitions were carried out for unaffected leg
Heel walking, walking for 20 meters on heel with heel pointing straight ahead, walking on heels with toes pointing out and walking on heels with toes pointing in After some brief rest the procedure is repeated once more
Cross leg body swing, leaning slightly forward with hands on wall for support and weight on affected leg other leg was swung in front of body positioning toes upward as foot reaches its farthest point of motion then swing the affected leg back to unaffected side as far as comfortably possible
|
| Comparator Agent |
strengthening exercises
Repetitions and sets Each exercise was performed For 3 sets of 10 repetitions
Resistance:
In first week with low resistance yellow band
In second week with moderate resistance red band
In third week with high resistance green band
Each group performed the exercises for duration of 30 minutes per day for 3 times a week for 8 weeks |
straight leg raise knee resisted exercises with theraband and ankle resisted exercises with theraband
Straight leg raise lie on back with hands by side Command the patient to lift the affected leg with straight knee not bend the knee during lifting leg up and hold it for 10 seconds with 3 sets for 10 repetatons
Knee resistive exercises subject performed knee flexion and extension resistive exercises with theraband
Knee flexion Prone Attach elastic to secure object Attach elastic to ankle of involved leg Lie face down Begin with knee straight Bend knee through available range Slowly return to starting position
Knee extension Prone Lie face down attach elastic to ankle Attach other end of elastic to secure object near head or shoulders Begin with knee bent Extend knee against pull of band Slowly return to start position and repeat
Ankle resistive exercises subject performed ankle plantarflexion, dorsiflexion inversion and eversion with theraband
Ankle inversion Long sitting Attach elastic to secure object1 Sit on floor with leg straight Attach elastic to forefoot Pull foot inward Slowly return and repeat
Ankle eversion Long sitting Attach elastic to secure object Sit on floor with leg straight Attach elastic to forefoot Pull foot outward slowly return and repeat
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Clinical diagnosis of diabetic neuropathy
Ability to participate in exercise programmes
Berg balance score should be between 21 to 40
|
|
| ExclusionCriteria |
| Details |
Severe musculoskeletal deformities
Vestibular dysfunction
Complete sensory loss
Cardiovascular complications limiting exercise
Lower extremity arthritis
Peripheral vascular disease
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Berg balance scale
Timed up and go test
Norfolk Quality of life questionnaire
|
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Timed up & go test
|
8 weeks |
| Norfolk Quality of life questionnaire |
8 weeks |
| Berg balance scale |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
04/05/2026 |
| 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="2"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
Response - None of the above
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kiranjallewar@gmail.com].
- For how long will this data be available start date provided 13-12-2025 and end date provided 15-05-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - no
|
|
Brief Summary
|
The present study was conducted to compare the effectiveness of proprioceptive training versus strengthening exercises in improving balance, functional mobility, and quality of life in patients with diabetic neuropathy. A total of 60 subjects were screened for eligibility, out of which 52 participants who met the inclusion criteria were selected for the study. Using convenient sampling, the participants were divided into two groups: Group A (Proprioceptive Training Group) and Group B (Strengthening Exercise Group). Group A received structured proprioceptive training exercises, while Group B underwent progressive strengthening exercises for the lower limbs. Both groups received intervention sessions for a specified duration under supervised physiotherapy care. Outcome measures used for assessment included the Berg Balance Scale (BBS) for balance, Timed Up and Go Test (TUG) for functional mobility, and Norfolk Quality of Life Questionnaire for Diabetic Neuropathy (Norfolk QOL-DN) for quality of life. Assessments were conducted at baseline and at the end of the intervention period. Statistical analysis was performed using paired and independent t-tests to evaluate intra-group and inter-group differences. The results demonstrated significant improvements in both groups across all outcome measures. However, Group A (proprioceptive training group) showed greater improvement in balance and quality of life, while Group B (strengthening group) demonstrated comparatively better improvement in functional mobility. These findings suggest that proprioceptive training is particularly effective in enhancing balance and improving quality of life in individuals with diabetic neuropathy, whereas strengthening exercises contribute significantly to improvements in functional mobility. Incorporating both approaches may provide comprehensive rehabilitation benefits for this population |