| CTRI Number |
CTRI/2023/10/059248 [Registered on: 30/10/2023] Trial Registered Prospectively |
| Last Modified On: |
28/10/2023 |
| 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
|
To check the effect of fast muscle activation with stepping training on balance and mobility in diabetic polyneuropathy patient |
|
Scientific Title of Study
|
Effectiveness of fast muscle
activation with stepping training for improving balance and mobility in diabetic
polyneuropathy: a randomized clinical 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 |
KORAT NIDHI |
| Designation |
MPT SCHOLAR |
| Affiliation |
Parul institute of physiotherapy,parul university |
| Address |
60 MUKTINAGAR-2
STATION RODE
SACHIN
SURAT
PG room number 401
Parul institute of physiotherapy
Parul university
waghodia
391760
Vadodara
GUJARAT
394230
India |
| Phone |
6354279527 |
| Fax |
|
| Email |
koratnidhi369@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrJoyal tejpal |
| Designation |
Assistant professor |
| Affiliation |
Parul institute of physiotherapy |
| Address |
staff room number 405
Parul institute of physiotherapy
Parul university
waghodia
GUJRAT
INDIA
Vadodara
GUJARAT
391760
India |
| Phone |
9909981454 |
| Fax |
|
| Email |
joyal.tejpal25384@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DrJoyal tejpal |
| Designation |
Assistant professor |
| Affiliation |
Parul institute of physiotherapy |
| Address |
staff room number 405
Parul institute of physiotherapy
Parul university
waghodia
GUJRAT
INDIA
Vadodara
GUJARAT
391760
India |
| Phone |
9909981454 |
| Fax |
|
| Email |
joyal.tejpal25384@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Parul Sevashram Hospital, P.O. Limda, Waghodia, Vadodara, Gujarat 391760 |
|
|
Primary Sponsor
|
| Name |
Parul Sevashram Hospital |
| Address |
Room No 231, Neuro Rehabilitation,
Parul Sevashram Hospital,
Vadodara, Gujarat 391760 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Nidhi Korat |
Parul Sevashram Hospital |
Room No 231, Neuro Rehabilitation, Parul Sevashram Hospital, Vadodara, Gujarat 391760
Vadodara
GUJARAT |
6354279527
koratnidhi369@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PARUL UNIVERSITY INSTITUTIONAL ETHICAL COMMITTEE FOR HUMAN RESEARCH (PU-IECHR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ACTIVE CONTROL PROGRAM |
[1] The task-specific practice of standing balance and walking activities
[2] Strengthening and endurance exercises.
[Note: There will be no specific training of fast stepping responses and no systematic training of fast over-ground walking (including treadmill training)].
ALL THE EXERCISES TO HAVE 3 SESSION PER WEEK FOR A TOTAL OF 4 WEEKS |
| Intervention |
FAST MUSCLE ACTIVATION WITH STEPPING TRAINING |
[1] Squats: (30 degrees of hip and knee flexion as fast as possible)
[2] Steps: Lean forward/ backward/ to the side Progression of step activities includes:
(A) Simple blocked practice: (Stepping leading with each leg in each direction is practiced in blocks of 10 repetitions)
(B) Semi-random practice: I. Stepping leading with each leg in each direction II. Stepping using alternate leading legs/leaning side.
(C) Random practice: Stepping leading with a leg in all 3 directions-forward, backwards and lateral alternatively one after other
(D) Random nomination of a lead leg with reduced movement planning time
(E) Concurrent task planning A simple concurrent cognitive task (e.g. counting backwards from 10) as they lean and step. • Repeat with (2a) and progress to (2c)
[3] Complementary activities to add to challenge and interest.
A. Step over 4 square exercises
B. Additional stepping and bounding activities.
ALL THE EXERCISES TO HAVE 3 SESSION PER WEEK FOR A TOTAL OF 4 WEEKS |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
[1] Pre-diagnose diabetes mellitus TYPE 2 for at least 5 years.
[2] BMI between 18.5 and 29.9 kg/m2.
[3] Ability to walk independently and ability stand on one leg.
[4] Patient examination based on Michigan neuropathy screening instrument.
[5] PATIENT FALL UNDER CLASS OF (ii) 2.6 – 4.5: mild neuropathy; (iii) 4.6 – 7.5: moderate neuropathy; ACCORDING TO FUZZY EXPERT SYSTEM
[6] Berge balance score should be >30/56.
|
|
| ExclusionCriteria |
| Details |
Diabetic ulcers in either foot.
Lack of blood sugar control.
Internal ear infections.
Other nervous system impairments (except neuropathy) or other diseases affecting balance.
Musculoskeletal problems such as vertebral column and limb deformity.
History of repeated ankle sprains in the year before.
Severe pain influencing balance, visual problems.
The existence of any other factors that interfere with balance except diabetic neuropathy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Berg balance scale |
Pre intervention (Base line) and Post intervention (after 12 sessions) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TIME UP AND GO TEST |
Pre intervention (Base line) & Post intervention (after 12 sessions)
|
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
08/11/2023 |
| 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 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
|
EFFECTIVENESS OF FAST MUSCLE ACTIVATION WITH STEPPING TRAINING ON BALANCE AND MOBILITY IN DIABETIC POLYNEUROPAYHT PATIENT: A RANDOMISE CONTROL TRAIL
AIM
THE STUDY AIMS TO EVALUTE THE EFFECTN OF FAST MUSCLE ACTIVATION WITH STEPPING TRAINING ON BALANCE AND MOBILITY IN DIABETIC POLYNEUROPATHY
OBJECTIVES
1.TO DETERMINE THE EFFECT OF FAST MUSCLE ACTIVATION WITH STEPPING TRAINING ON BALANCE IN A PATIENT WITH POLYNEUROPATHY.
2.TO DETERMINE THE EFFECT OF FAST MUSCLE ACTIVATION WITH STEPPING TRAINING ON MOBILITY IN A PATIENT WITH DIABETIC POLYNEUROPATHY.
|