| CTRI Number |
CTRI/2025/03/082056 [Registered on: 10/03/2025] Trial Registered Prospectively |
| Last Modified On: |
09/03/2025 |
| 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
|
Boosting Balance: How Adapted Sports Improve Nerve Reflexes in Seniors |
|
Scientific Title of Study
|
Efficacy of adapted sports program on improving postural stability in elderly individuals |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditi Sharma |
| Designation |
PG Student |
| Affiliation |
SGT University |
| Address |
SGT University Gurugram Haryana India
NIL
Gurgaon
HARYANA
122505
India |
| Phone |
8544788657 |
| Fax |
NIL |
| Email |
aditisharmaa8546@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aarti Gupta |
| Designation |
Assistant Professor |
| Affiliation |
SGT University |
| Address |
SGT University Gurugram Haryana India
NIL
Gurgaon
HARYANA
122505
India |
| Phone |
9958995444 |
| Fax |
NIL |
| Email |
aarti_fphy@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinika Chaudhary |
| Designation |
Assistant Professor |
| Affiliation |
SGT University |
| Address |
SGT University Gurugram Haryana India
NIL
Gurgaon
HARYANA
122505
India |
| Phone |
9650922399 |
| Fax |
NIL |
| Email |
vinika_fphy@sgtuniversity.org |
|
|
Source of Monetary or Material Support
|
| SGT University Gurugram Haryana India PIN 122505 |
|
|
Primary Sponsor
|
| Name |
Aditi Sharma |
| Address |
SGT University Gurugram Haryana India PIN 122505 |
| Type of Sponsor |
Other [Self] |
|
|
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 Aditi Sharma |
SGT University |
SGT University Faculty of Physiotherapy D block Basement Gurugram Haryana India PIN 122505
Gurgaon
HARYANA |
8544788657
aditisharmaa8546@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Faculty of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal Healthy elderly population |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A (Adapted Sports via Xbox Kinect) |
The Following games in Your Shape: Fitness Evolved II, Kinect adventure and Kinect sports rivals will be used for training older adult’s postural stability, static and dynamic balance, proprioception and lower-body endurance. The games are Zen energy, Cardioboxing, Destination Bollywood, Human Vitality, Soccer, Jet ski, Tennis, Cool down.
Duration and Frequency: ^ weeks 3 session per week for 45 minutes. |
| Comparator Agent |
Group B (Traditional Balance Exercises) |
Stretching (Calf and Hamstring),
Standing on One Leg,
Tandem Stance (Heel-to-Toe), Semi-Tandem Stance (Heel-to-Midfoot)
Side-to-Side Weight Shifts
Walking Heel-to-Toe (Forward & Backward)
Step-Ups (Low platform)
Heel-Toe Raises on balance board
Squats on Board
Forward-Backward Rocks
Lateral Shuffles
Standing Marches
Combined Pursed-Lip & Diaphragmatic Breathing
Visualization Breathing
Duration and Frequency: 6weeks 3 session per week for 45 minutes
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
79.00 Year(s) |
| Gender |
Both |
| Details |
1. Older adults 60- 79 years old.
2. Having normal cognitive comprehension abilities and a score of at least 24 points on the Mini Mental State Examination (MMSE).
3. Undergone confirmations of disease history and health status through answering a health survey and the Physical Activity Readiness Questionnaire (PAR-Q) to ensure safety of the training.
|
|
| ExclusionCriteria |
| Details |
1.Inability to stand and walk for 3 minutes without walking aid.
2.Cognitive impairments.
3.Orthopaedic, cardiovascular and neurological disease.
4.Use of medicines that hampers balance.
5.Severe visual and auditory impairments.
6.Participants practicing sports that explicitly include balance component.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postural Stability (H-Reflex) |
At week 0 and by the end of week 6. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mini- Bestest
One leg stance test.
Time Up and Go (TUG) Test.
Proprioception (Bubble Inclinometer)
Strength (Dynamometer)
|
At week 0 and by the end of week 6. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/03/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 explores the impact of balance and strength training, facilitated through adapted sports using Xbox Kinect technology, on H-reflex responses in older adults. Aging leads to declines in balance and neuromuscular control, increasing fall risks. Adapted sports provide an engaging alternative to traditional exercise, leveraging Xbox’s interactive features and motion-sensing capabilities to enhance motivation, adherence, and training outcomes.The study aims to measure neuromuscular adaptations using H-reflex assessments, which evaluate spinal motor neuron excitability, before and after training. By integrating Xbox for tailored balance and strength exercises, the research seeks to improve postural stability, strength, and neuromuscular control in the elderly, addressing gaps in research on adapted sports for healthy older populations. Traditional exercises for older individuals may lose appeal over time, leading to decreased motivation and adherence. Introducing adapted sports through Xbox offers an interactive and stimulating alternative, rekindling interest in staying active while improving balance, proprioception, and strength. Additionally, exploring the impact on the H reflex can unveil how these activities affect neuromuscular function, potentially reducing the risk of falls. Null Hypothesis H (0)1: There will be no significant difference in postural stability among elderly people who participate in adapted sports. H (0)2: There will be no significant difference in balance, proprioception and strength among elderly people who participate in adapted sports Alternate Hypothesis H1: There will be a significant difference in postural stability among elderly people who participate in adapted sports. H2: There will be a significant difference in balance, proprioception and strength among elderly people who participate in adapted sports.
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