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CTRI Number  CTRI/2024/09/074259 [Registered on: 24/09/2024] Trial Registered Prospectively
Last Modified On: 23/09/2024
Post Graduate Thesis   
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 sensorimotor exercise in Elderly: A Randomized Controlled Trial 
Scientific Title of Study   Effect of sensorimotor exercise in community-dwelling older adults: A Randomized Controlled 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  Kazi Md Azman Hossain 
Designation  Final Year Bachelor of Physiotherapy (BPT) Student 
Affiliation  Jashore University of Science and Technology (JUST) 
Address  Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore 7408



7408
Other 
Phone  01660140833  
Fax    
Email  azmanhossain51@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Md Feroz Kabir 
Designation  Assistant Professor 
Affiliation  Jashore University of Science and Technology (JUST) 
Address  Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore 7408



7408
Other 
Phone  01765932545  
Fax    
Email  feroz@just.edu.bd  
 
Details of Contact Person
Public Query  
Name  Dr. Tofajjal Hossain 
Designation  MPT Fellow 
Affiliation  Jashore University of Science and Technology (JUST) 
Address  Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore 7408



7408
Other 
Phone  01778790798  
Fax    
Email  tofajjalhossainphysio@gmail.com  
 
Source of Monetary or Material Support  
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh. 
 
Primary Sponsor  
Name  Kazi Md Azman Hossain 
Address  Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh. 
Type of Sponsor  Other [Self-funding] 
 
Details of Secondary Sponsor  
Name  Address 
Jashore University of Science and Technology JUST  Jashore University of Science and Technology (JUST), Jashore - 7408 
 
Countries of Recruitment     Bangladesh  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Md Kabir Hossain  Dr. M R Khan Medical Centre  Room no: 306, 2nd Floor, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore 7408, Bangladesh.

 		 01778315139

kabir2002pt@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board (IRB) of Institute of Physiotherapy Rehabilitation and Research (the academic institute of BPA)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  community-dwelling older adults 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional care  Six weeks for 18 sessions(3 sessions/week). At first, warm-up session including light walking and marching, specific joint exercise for 5-10 minutes. After the warm-up, complete hamstrings, calf, quadriceps, neck and hand stretching for 3-5 repetitions with 15-30 seconds hold during each repetitions; strengthening exercise including bridging in back and prone position (using gym ball for 10 repetitions × 1-2-3 sets), U/L and L/L theraBand exercise (knee flexion-extension and abduction-adduction, shoulder abduction, arm curl for 10 repetitions × 1-2-3 sets), hand exercise (using squeeze ball 10 repetitions × 1-2-3 sets). At last cool down for 5 minutes. 
Intervention  Sensorimotor exercise along with conventional care  Six weeks for 18 sessions(3 sessions/week). At first, conventional care including warm-up, stretching, and strengthening exercise. After that, participants will perform six sensorimotor exercise. This include single leg stance, exercise on wobble board, star excursion balance exercise, tandem walking, colored path exercise and obstacle on path exercise. At last cool down for 5 minutes. 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  79.00 Year(s)
Gender  Both 
Details  Individuals will be included in this trial if (1) Male and female aged 65-79 years, (2) can stand with or without walking aids, (3) Mini-Mental Status Examination (MMSE) score ≥ 18, (4) Physical Performance Battery score ≤ 6. Here, scoring ≤6 points on the Short Physical Performance Battery defines poor physical performance also indicates the risk of sarcopenia. 
 
ExclusionCriteria 
Details  Individuals will be excluded if (1) Severe visual disturbances, (2) prosthetic limb, (3) any soft tissues or joint injury, fractures in last three months, (4) diagnosis of severe heart disease or uncontrolled systemic arterial hypertension, (5) diagnosis of cancer and receiving palliative care, (6) taking psychotropic, antiarrhythmic, or hypnotic drugs.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Static balance (OLS), functional balance (FRT), functional mobility (TUG), activities-specific balance confidence scale (ABC scale), Tinetti performance-oriented mobility assessment (POMA), Physical performance (SPPB), fall risk (FES-I), aerobic capacity (6MWT)  5 months 
 
Secondary Outcome  
Outcome  TimePoints 
Pain (NPRS), muscle strength (Sphygmomanometer), exercise motivation (BREQ-3), functional independence (Barthel index), quality of life (SF-36), physical self-maintenance scale (PSMS), cognitive impairment (MMSE), depression severity (GDS-15)  5 months 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="0" 
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)   05/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  05/10/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="5"
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  

We plan to carry out six weeks randomized controlled trial. We will compare the effectiveness between sensorimotor exercise along with conventional care and conventional care only in community-dwelling older adult. This study aims to determine the community-dwelling older adults’ sociodemographic characteristics, baseline comparison at pretest and determine the effectiveness of sensorimotor exercise on overall function and quality of life during the posttest and twelve-weeks follow-up also. We expect better treatment outcome after 18 sessions of intervention in community-dwelling older adult who receive sensorimotor exercise along with conventional care.

 
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