| CTRI Number |
CTRI/2025/02/080684 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| 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
|
Effect of voluntary stepping training in different directions in a specific pattern in adults between 60 – 70 years |
|
Scientific Title of Study
|
Effect of a structured volitional step training on the attributes of reactive stepping in the elderly population |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raajashri S |
| Designation |
Student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Room no: 2.2, 2nd floor, Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai, Tamil Nadu 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
6385514169 |
| Fax |
|
| Email |
raajashris0801@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr RSivakumar |
| Designation |
Professor, Faculty of physiotherapy |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
3rd floor, Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai, Tamil Nadu 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9840068412 |
| Fax |
|
| Email |
rsivkumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrR Sivakumar |
| Designation |
Professor, Faculty of physiotherapy |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
3rd floor, Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai, Tamil Nadu 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9840068412 |
| Fax |
|
| Email |
rsivkumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu, India. |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu, India. |
| Type of Sponsor |
Research institution and hospital |
|
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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 |
| DrRaajashri S |
SRIHER - Faculty of Physiotherapy OPD |
Room no: 2.2, 2nd floor, Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai, Tamil Nadu 600116
Chennai
TAMIL NADU |
6385514169
raajashris0801@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE FOR STUDENTS PROJECTS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Elderly population between 60 - 70 years and above who have no limb length discrepancies, lower limb or spinal deformities. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional step training |
In conventional step training, participants will be required to perform a sequence of steps at their own speed, starting with symmetrical weight bearing -first direction, followed by a sideway step - second direction, forward step - third direction, and backward step - fourth direction, always returning to the first direction. Rest periods between each position will be part of the procedure, as explained at the start. Participants will complete 10 quick steps in each position for 5 sets. It will be provided for 5 days in total with 2 sessions per day. |
| Intervention |
Modified Choice Stepping Reaction Training (CSRT-M) |
Modified choice stepping reaction time (CSRT-M) intervention involves a thin flexible non-slip mat (80cm x 120cm) marked with two rectangular standing panels (28.5cm x 13.5cm) and four rectangular stepping panels (28.5cm x 13.5 cm), one in each front of each standing panel and one on each side.In the CSRT-M, verbal commands will be used to instruct the step (i.e. place the whole foot) onto specific rectangle panels in a set sequence of 20 steps as quickly as possible. Subjects will be asked to follow the instructions and place their foot in the relevant boxes. The left foot will be placed in the left side boxes and the right foot in the right boxes. The stepping will be done as quickly as possible and the foot should be returned to the central boxes quickly. The instructions for stepping will be based on the standard commands given for the test- Intervention will be provided for 5 days in total with 2 sessions per day. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Elderly adults of both genders, aged 60 -70 years
Elderly adults with no limb length discrepancies.
Elderly adults with no lower limb or spinal deformities.
Ability to comprehend instructions
|
|
| ExclusionCriteria |
| Details |
Elderly adults with the presence of pain or history of fractures in the lower extremity joints or spine.
Elderly adults with neurological and cardiorespiratory disorders.
Elderly adults with recent surgeries.
|
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
First Step Length (cm)
Measurement: Distance (in cm) from the initial position to the first step after perturbation.
Step Duration (seconds)
Measurement: Time (in seconds) taken to complete the first reactive step after perturbation.
Balance Recovery Distance (cm)
Measurement: Distance (in cm) covered by the participant to regain balance after the first reactive step.
|
Evaluated at baseline and post-intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Measure the number of steps taken and the first foot used during reactive stepping in both young and elderly populations.
Compare the effects of structured voluntary step training versus conventional step training on step initiation patterns and stepping strategies. |
Throughout the study |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
28/02/2025 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Falls pose a major risk, particularly for older adults and individuals with balance impairments, often leading to severe injuries and reduced quality of life. Reactive stepping, a quick step taken to regain balance after a perturbation, plays a crucial role in fall prevention. While both reactive and volitional step training improve balance, volitional training typically lacks a focus on step speed and execution time. This study explores whether volitional step training, when structured to emphasize speed, can enhance reactive stepping ability. The Choice Stepping Reaction Time (CSRT) test, introduced by Professor Stephen Lord, assesses voluntary stepping in a structured manner and reflects essential balance control mechanisms. A modified version, CSRT-M, offers a time-bound approach, motivating individuals to complete steps within a specific timeframe. We hypothesize that volitional step training using CSRT-M, combined with performance feedback, can improve reactive stepping characteristics—first step time, first step distance, and balance recovery distance—more effectively than conventional step training. This study evaluates these effects in both young adults and the elderly. |