| CTRI Number |
CTRI/2025/06/089389 [Registered on: 23/06/2025] Trial Registered Prospectively |
| Last Modified On: |
20/06/2025 |
| 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
|
Exploring the Role of Feedback Timing on Balance Skill Learning in Young versus Older Adults |
|
Scientific Title of Study
|
Effect Of Concurrent Feedback Frequencies on Motor Learning in Postural Control Task Among Different Age Groups |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nabiyah Sajjad |
| Designation |
Post Graduate Scholar |
| Affiliation |
Jamia Hamdard |
| Address |
Room No.9, Rehabilitation Centre, Department of Physiotherapy, Jamia Hamdard, New Delhi
South DELHI 110062 India |
| Phone |
9528856866 |
| Fax |
|
| Email |
nabiyasjd@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prachi Tiwari |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Hamdard |
| Address |
Room No.543, 5th Floor, Central Library Building, Department of Physiotherapy, Jamia Hamdard, New Delhi
South DELHI 110062 India |
| Phone |
9811644726 |
| Fax |
|
| Email |
prachi.tiwari@jamiahamdard.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Prachi Tiwari |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Hamdard |
| Address |
Room No.543, 5th Floor, Central Library Building, Department of Physiotherapy, Jamia Hamdard, New Delhi
DELHI 110062 India |
| Phone |
9811644726 |
| Fax |
|
| Email |
prachi.tiwari@jamiahamdard.ac.in |
|
|
Source of Monetary or Material Support
|
| Jamia Hamdard, Hamdard Nagar, New Delhi - 110062 |
|
|
Primary Sponsor
|
| Name |
Jamia Hamdard |
| Address |
Hamdard Nagar, New Delhi - 110062 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Prachi Tiwari |
Jamia Hamdard |
Room No.9, Rehabilitation Centre, Department of Physiotherapy, Jamia Hamdard, New Delhi South DELHI |
9811644726
prachi.tiwari@jamiahamdard.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jamia Hamdard Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Static Balance and Dynamic Balance |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Concurrent Feedback |
The experimental task was designed to assess postural control using visual biofeedback.
Participants were instructed to stand barefoot on a standardized force platform in a bipedal stance with their feet shoulder-width apart.
The center of pressure was monitored during each trial. Each trial lasted 30 seconds, with 30 second rest intervals between trials to avoid fatigue.
A visual fixation point was displayed 1 meter in front of the participants at eye level.
Consistent foot placement was ensured using floor markers, and participants were instructed to maintain their arms by their sides throughout the task.
The Concurrent Feedback Group received continuous visual feedback during all training trials.
|
| Comparator Agent |
Control |
The Control Group performed the task with no feedback, focusing only on the fixation point. |
| Comparator Agent |
Intermittent Feedback |
The experimental task was designed to assess postural control using visual biofeedback. Participants were instructed to stand barefoot on a standardized force platform in a bipedal stance with their feet shoulder-width apart. The center of pressure was monitored during each trial. Each trial lasted 30 seconds, with 30 second rest intervals between trials to avoid fatigue. A visual fixation point was displayed 1 meter in front of the participants at eye level. Consistent foot placement was ensured using floor markers, and participants were instructed to maintain their arms by their sides throughout the task. The Intermittent Feedback Group received visual feedback during 8 out of the 12 trials. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects had no history of injury within the past six months.
2. Both male and female subjects.
3. Subjects with a body mass index ranging from 18.5 to 24.9 kilogram per meter square.
5. Subjects are able to comprehend instructions and successfully complete the testing protocol.
|
|
| ExclusionCriteria |
| Details |
1.Subjects with a recent episode of concussion/ traumatic brain injury.
2.Subjects with a diagnosed cervical radiculopathy or any nerve root involvement.
3.Subjects with a history of osteoporosis.
4.Subjects having undergone neck surgery during the past twelve months.
5.Subjects with uncontrolled diabetes with and without peripheral neuropathy.
6.Subjects with diagnosed vestibular, balance impairments.
7.Recent history of injury or trauma to the upper limb.
8.Subjects having any drug abuse.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Centre of Pressure, Limit of Stability |
Baseline, After Intervention, After 24 hours |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
04/07/2025 |
| 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
|
Following the application of the inclusion and exclusion criteria, a total of ninety participants will be selected using a convenience sampling technique. Prior to participation, each individual will receive a detailed verbal and written explanation regarding the objectives, methodology, potential benefits, and anticipated risks of the study. Written informed consent will be obtained from all eligible volunteers in accordance with ethical research standards. Participants will then be allocated into groups based on their age—either 18–24 years or 25–30 years—and further assigned to experimental or control conditions according to the visual feedback frequency they will receive. The experimental conditions will consist of two types of concurrent visual feedback: 100% feedback (provided after every trial) and 67% feedback (provided in two out of every three trials). These feedback frequencies will be selected based on established principles in motor learning research, where reduced frequency has been shown to facilitate better retention and autonomous control (8,28). The control group will receive no feedback (0%). Each participant will attend the research laboratory for two consecutive days. On the first day, demographic and anthropometric data, including age, height, weight, and body mass index (BMI), will be recorded. Participants will then undergo a pre-test consisting of a standardized postural control task, followed by a structured training session under their assigned feedback condition. Immediately after the training, a post-test will be administered using the same task protocol to assess immediate learning effects. On the second day, approximately 24 hours later, participants will return for a retention test using the same setup to evaluate the consolidation and retention of motor learning. The primary outcome measure will be the Center of Pressure (CoP) excursion, which will be recorded through a force platform or equivalent system, with performance being evaluated across the pre-test, post-test, and retention phases. All sessions will be conducted under standardized conditions, and participants will receive consistent instructions to ensure reliability and control of confounding variables throughout the study. |