| CTRI Number |
CTRI/2024/07/069959 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
02/07/2024 |
| 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 study how two different type of Training Programs can help older adults improve balance , walking speed and reduce their risk of fall. |
|
Scientific Title of Study
|
Effectiveness Of Proprioceptive Training And Motor Dual Task Training On Impaired Balance , Gait Speed And Risk Of Fall In Older Adult : A 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 |
Dr Abdur Raheem Khan |
| Designation |
Head And Professor Department Of Physiotherapy |
| Affiliation |
Integral University |
| Address |
Department Of Physiotherapy, Integral University, Dasauli, Kursi Road, Lucknow, 226026
Lucknow
UTTAR PRADESH
226026
India |
| Phone |
9616739965 |
| Fax |
|
| Email |
abdurraheem@iul.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeraj Kumar Maurya |
| Designation |
Associate Professor, Department Of Physiotherapy |
| Affiliation |
Integral University |
| Address |
Department Of Physiotherapy, Integral University, Dasauli, Kursi Road, Lucknow, 226026
Lucknow
UTTAR PRADESH
226026
India |
| Phone |
9897804465 |
| Fax |
|
| Email |
nkmaurya@iul.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Sonam Rai |
| Designation |
Masters Of Physiotherapy (MPT) |
| Affiliation |
Integral University |
| Address |
Department Of Physiotherapy, Integral University, Dasauli, Kursi Road, Lucknow, 226026
Lucknow
UTTAR PRADESH
226026
India |
| Phone |
9304668924 |
| Fax |
|
| Email |
sonam.roy1716@gmail.com |
|
|
Source of Monetary or Material Support
|
| Integral University, Kursi road, Dashauli, Lucknow, UP, India 226026 |
|
|
Primary Sponsor
|
| Name |
Dr Neeraj Kumar Maurya |
| Address |
Department Of Physiotherapy, Integral University, Dasauli, Kursi Road, Lucknow, 226026 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Self |
Department Of Physiotherapy, Integral University, Dasauli, Kursi Road, Lucknow, 226026 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neeraj Kumar Maurya |
Integral University, Lucknow |
Department Of Physiotherapy, Integral University, Dasauli, Kursi Road, Lucknow- 226026
Lucknow
UTTAR PRADESH |
9897804465
nkmaurya@iul.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Integral University, Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Older Adult With Impaired Balance, Gait Speed And Risk Of Fall |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Control Group: No Intervention will be given. Control group only receive Fall Prevention Guidelines (For 6 weeks ) |
| Intervention |
Motor Dual Task Training |
Motor Dual Task Training:
For 6 six week (2 days/week), 45 min training session
(Initial Phase)- Eyes open and closed while tandem walking on the floor, Reciting a number, a day, or a month backwards while stepping over an Obstacles i.e., Cone,Walking while raising object using both hand. (Intermediate Phase)- Walk 10-meter backwards while holding ball in one hand, Carrying one or two balls while walking, Walking between two chairs in an 8-shaped pattern, Walking on the floor with rotated head. (Advance Phase)- Carrying an object while tandem walking, Throwing and catching an object with quickly altering hand motions while walking.
|
| Intervention |
Proprioceptive training |
Proprioceptive Training:
For 6 six week (2 days/week), 45 min training session
(Initial phase)- Alternate knee flexion-extension with extended trunk posture using both hands for support, Hip and knee flexion-extension with Swiss ball between the back and wall, Walking on the line, Tandem walk,(Intermediate Phase)-Alternate knee flexion-extension using the homolateral upper limb for support, Hip and knee flexion-extension with Swiss ball between the back and wall, Backward walk, High march walk,(Advance Phase)-Alternate knee flexion-extension with no upper limb support, High march backward walk, High march tandem backward walk.
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Those who ambulate independently without any assistance devices, On the Berg Balance Score (BBS) those with a score of less than 52 (out of a possible 56) were deemed to have balance impairment, Those who participating voluntarily in the study. |
|
| ExclusionCriteria |
| Details |
Cardiovascular, musculoskeletal, or severe neurological diseases (such as Parkinson’s and multiple sclerosis),
Significant hearing or visual impairment,
Participation in a regular strength, balance, or dual-task training program past 6 months,
History of hip-knee surgery.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Berg Balance Scale (BBS)
Time Up And Go Test (TUG)
Fall Efficacy Scale International (FES-I)- |
At Baseline, After 2 Weeks, After 4 Weeks, After 6 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
20/07/2024 |
| 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="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
|
This Study Is A Randomized , Double Blind, Parallel Group , Single Centre Trail Comparing The Effect Of Proprioceptive Training ( 45 min/ session, 2 days/wk for 6 weeks) And Motor Dual Task Training ( 45 min/ session, 2 days/wk for 6 weeks) On Older Adult With Impaired Balance , Gait Speed And Risk Of Fall That Will Be Conducted In Single Centre, Integral University , Lucknow, India. The Primary Outcome Measure Will be Berg Balance Scale( BBS ), Time Up And Go Test ( TUG), Fall Efficacy Scale- International (FES-I) And That will Be Evaluated At Baseline , After 2 weeks , After 4 weeks, After 6 Weeks. |