| CTRI Number |
CTRI/2021/11/038201 [Registered on: 23/11/2021] Trial Registered Prospectively |
| Last Modified On: |
18/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
EFFECT OF BALANCE ENHANCED EXERCISE PROGRAM (BEEP) ON BALANCE, BALANCE CONFIDENCE, AND NERVE CONDUCTION IN PATIENTS WITH DIABETIC PERIPHERAL NEUROPATHY. |
|
Scientific Title of Study
|
EFFECT OF BALANCE ENHANCED EXERCISE PROGRAM (BEEP) ON BALANCE, BALANCE CONFIDENCE, AND NERVE CONDUCTION IN PATIENTS WITH DIABETIC PERIPHERAL NEUROPATHY: A RANDOMIZED CONTROL TRIAL. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sharvari Samant |
| Designation |
Post Graduate Student |
| Affiliation |
Dr. D Y Patil College of Physiotherapy, Pune |
| Address |
Dr.D.Y.Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9987221179 |
| Fax |
|
| Email |
sharvari.samant11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preeti Gazbare |
| Designation |
Associate Professor |
| Affiliation |
Dr. D Y Patil College of Physiotherapy, Pune |
| Address |
Sukhwani Campus, vallabh Nagar, Pune
Dr.D.Y.Patil College of Physiotherapy, Dr. D Y Patil Vidyapeeth, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9096116134 |
| Fax |
|
| Email |
preeti.gazbare@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preeti Gazbare |
| Designation |
Associate Professor |
| Affiliation |
Dr. D Y Patil College of Physiotherapy, Pune |
| Address |
Sukhwani Campus, vallabh Nagar, Pune
Dr.D.Y.Patil College of Physiotherapy, Dr. D Y Patil Vidyapeeth, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9096116134 |
| Fax |
|
| Email |
preeti.gazbare@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sharvari Samant |
| Address |
4/51, Sujalshree Building, Datar Colony Road, Bhandup East, Mumbai 400042 |
| 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 |
| Sharvari Samant |
Dr. D Y Patil Hospital and Dr. D Y Patil College of Physiotherapy |
3rd floor, Neurosciences Department, Sant Tukaram Nagar, Pimpri, Pune 411018
Pune
MAHARASHTRA |
9987221179
sharvari.samant11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. D Y Patil Vidyapeeth |
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: G64||Other disorders of peripheral nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BALANCE ENHANCED EXERCISE PROGRAM |
3 week intervention
Knee squats
Heel /calf raising
One leg standing
Head rotations
Rotational jumps |
| Comparator Agent |
Conventional protocol |
3 week intervention
stable to unstable base of support: bipedal to semi-tandem, tandem to one leg stance, Surface: from broad to decrease surface, changes in speed of different activities for static balance, reaching activities. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Type II Diabetes Mellitus
Berg Balance Scale Score [21-50]
Michigan Diabetic Neuropathy Screening Instrument
|
|
| ExclusionCriteria |
| Details |
Diabetic ulcers in either foot
Other neurological impairments affecting balance (ataxia, Parkinson’s disease etc. except peripheral neuropathy)
Severe lower limb, spinal injury or deformity which makes the patient unable to exercise.
Patient with cardiac abnormality with an ejection fraction of <30%
Pain in the lower extremities, lower back, lumbar radiculopathy etc - VAS- >75mm
|
|
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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 |
Balance by using Balance Master
Activities Specific Balance Confidence Scale (ABC)
Nerve Conduction Velocity (NCV) |
3 weeks intervention
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SF 36 Questionnaire for quality of life |
3 weeks intervention |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/11/2021 |
| Date of Study Completion (India) |
04/04/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Diabetes negatively affects the peripheral nerve
function leading to postural instability by altering the balance. The Balance
Enhanced Exercise Program (BEEP) protocol emphasizes on all the systems
affected in diabetic peripheral neuropathy (DPN) patients - musculoskeletal,
somatosensory, vestibular. Since, implementing this
protocol on older adults have shown effect, there is a need to study the effect
of BEEP on balance, balance confidence and nerve conduction in patients with
DPN.
AIM:
To
study the effect of balance enhanced exercise program (BEEP) on balance,
balance confidence and nerve conduction in patients with diabetic peripheral
neuropathy, with the objective to
study the effect of BEEP on balance using balance master (LOS & CTSIB), on
balance confidence using Activities-Specific Balance Confidence (ABC) Scale,
and nerve conduction velocity using Nerve conduction velocity study.
NULL HYPOTHESIS: Balance enhanced exercise program (BEEP) does
not have an effect on balance, balance confidence and nerve conduction in patients
with diabetic peripheral neuropathy.
|