| CTRI Number |
CTRI/2024/06/069325 [Registered on: 20/06/2024] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of video game based daily activity training on hand function and reaction time in young and middle-aged elderly: An Experimental study |
|
Scientific Title of Study
|
Effect of Activities of Daily Living simulated exergaming on hand function and reaction time in young and middle old elderly: An Experimental study |
| 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 Vidhi Hitesh Doshi |
| Designation |
Masters of Neurophysiotherapy Student |
| Affiliation |
K J Somaiya College of Physiotherapy,Sion |
| Address |
K J Somaiya College of Physiotherapy, Adult Neuro Rehabilitation OPD number 10, Ayurvihar, Eastern Express
Highway, Sion Mumbai MAHARASHTRA
400022
Mumbai MAHARASHTRA 400022 India |
| Phone |
08291706828 |
| Fax |
|
| Email |
vidhi.doshi@somaiya.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mugdha Oberoi |
| Designation |
Associate Professor |
| Affiliation |
K J Somaiya College of Physiotherapy,Sion |
| Address |
K J Somaiya College of Physiotherapy, Adult Neuro Rehabilitation OPD number 10, Ayurvihar, Eastern Express
Highway, Sion Mumbai MAHARASHTRA
400022
Mumbai MAHARASHTRA 400022 India |
| Phone |
9820585119 |
| Fax |
|
| Email |
mugdha@somaiya.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Mugdha Oberoi |
| Designation |
Associate Professor |
| Affiliation |
K J Somaiya College of Physiotherapy,Sion |
| Address |
K J Somaiya College of Physiotherapy, Adult Neuro Rehabilitation OPD number 10, Ayurvihar, Eastern Express
Highway, Sion Mumbai MAHARASHTRA
400022
Mumbai MAHARASHTRA 400022 India |
| Phone |
9820585119 |
| Fax |
|
| Email |
mugdha@somaiya.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
K J Somaiya College of Physiotherapy, |
| Address |
K J Somaiya College of Physiotherapy, Adult Neuro Rehabilitation OPD number 10, Ayurvihar, Eastern Express
Highway, Sion Mumbai MAHARASHTRA
400022 |
| 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 Vidhi Hitesh Doshi |
K J Somaiya College of Physiotherapy |
K J Somaiya College of Physiotherapy, Adult Neuro Rehabilitation OPD number 10, Ayurvihar, Eastern Express
Highway, Sion Mumbai MAHARASHTRA
400022 Mumbai MAHARASHTRA |
08291706828
vidhi.doshi@somaiya.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee K J Somaiya College of Physiotherapy |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Community dwelling Elderly People in age group 60-80 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Activities of Daily Living Simulated exergaming |
Elderly patients will be given Activities of Daily Living (ADL) simulation training using ADL simulated mode of Mobi L of Rymo Technologies Pvt.Ltd. company. Safety precautions will be taken throughout the treatment. The participant will be sitting on a chair. Researcher will be by the side of the patient. Height will be adjusted according to the participant and the tablet will be kept at eye level of the patient on one side at an angle of 40-45 degrees. After every game, time required to change the game will serve as a rest period which will be approximately 1 minute. Additionally, if they require a rest period in between then that will also be given. The games include: 1)House vault training using door knob and key attachments 2)Gardening using Forearm pronation and supination attachments, 3)Pack your bag: using Wrist flexion and extension attachment, 4)Stamping using Shoulder internal and external rotation attachment Each game will be given for 10 repetitions each for both hands. The intervention will be 5 sessions/week for 2 weeks Intensity will be submaximal resistance for both hands. |
| Comparator Agent |
Exercise which will be similar to Exergaming Group but without ADL simulation and visual feedback using Yellow Theraband |
Exercises using Yellow Theraband will include Wrist flexion and extension, Forearm pronation and supination, Shoulder internal and external rotation. There will be 10 repetitions each for both the hands. The intervention will be for 5 sessions/ week for 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
60 to 80 years community dwelling elderly able to understand and follow instructions
in English
Individuals of all genders
Individuals scoring more than 3 in Mini-Cog scale
|
|
| ExclusionCriteria |
| Details |
1. Individuals with any uncorrected visual or auditory impairment.
2. Individuals with a history of surgical, traumatic, inflammatory musculoskeletal
condition, unstable angina or any neurological conditions or any acute upper limb
injury in the past 6 months.
3. Any hospitalisation in the past 6 months. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Minnesota Manual Dexterity test for gross motor skills
2.Purdue Pegboard test for fine motor skills
3. Duruoz Hand Index- self-reported questionnaire for assessing the hand activity limitation and its effect on ADLs
4. Deary Liewald reaction time test |
(a) Pre-treatment assessment
(b) After one week of intervention
(c) After two weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="64" Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="66" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| Date of Study Completion (India) |
30/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This experimental study aimed to evaluate the effect of Activities of Daily Living (ADL)-simulated exergaming on hand function and reaction time in young-old and middle-old elderly individuals. Primary Objectives: 1. To assess hand function (gross motor, fine motor, and functional limitation) in the Exergaming group pre-intervention, after one week, and after two weeks using the Minnesota Manual Dexterity Test (MMDT), Purdue Pegboard Test (PPT), and Duruoz Hand Index (DHI). 2. To assess hand function in the control exercise group at the same three time points using the same outcome measures. 3. To assess reaction time in the Exergaming group pre-intervention, after one week, and after two weeks using the Deary–Liewald Reaction Time Test (DLRT). 4. To assess reaction time in the control group at the same three time points using the DLRT. 5. To compare hand function between the Exergaming and control groups using MMDT, PPT, and DHI. 6. To compare reaction time between the Exergaming and control groups using the DLRT. Methods: This experimental study included 66 participants, with 33 in the Exergaming group and 33 in the control group. The intervention lasted for two weeks, with 10 supervised sessions administered. Data were analysed using GraphPad Prism 10 Free version. The Shapiro–Wilk test assessed normality. Within-group comparisons at three time points (pre-intervention, post-1-week, post-2-weeks) were analysed with Repeated Measures ANOVA for MMDT, PPT, and DLRT. For DHI (non-parametric), the Wilcoxon matched-pairs signed-rank test was used. Between-group comparisons were analysed with One-Way ANOVA and Tukey’s post-hoc test for parametric data, and the Mann–Whitney U test for DHI. A significance level of p < 0.05 was maintained. Results: Both groups demonstrated improvement in hand function over the intervention period; however, participants in the Exergaming group showed significantly greater gains compared to the control group. Improvements were observed consistently across the Minnesota Manual Dexterity Test (MMDT), Purdue Pegboard Test (PPT), and Duruoz Hand Index (DHI), indicating enhanced gross and fine motor dexterity as well as better self-reported functional hand use. In terms of reaction time, the Exergaming group exhibited significant reductions in Deary-Liewald Reaction Time (DLRT) scores for both simple and choice reaction time, reflecting faster processing speed and improved motor responsiveness. The control group also demonstrated some improvement, though to a lesser extent. When comparing groups, the Exergaming intervention outperformed the control intervention across all primary outcome measures. Statistically significant between-group differences were observed in MMDT, PPT, DHI, and DLRT, confirming that exergaming provided superior benefits for both hand function and reaction time relative to traditional exercises. Conclusion: All study objectives were successfully fulfilled. ADL-simulated exergaming was found to be a feasible and effective intervention to enhance hand function and reduce reaction time in elderly individuals, and it may be considered as a useful adjunct in geriatric rehabilitation programs. The findings emphasize that rehabilitation strategies which integrate biological (motor function), psychological (cognitive-motivational), and social (participation, independence) domains may yield more holistic and sustainable outcomes in the elderly. ADL-simulated exergaming therefore represents not only an effective motor training tool but also a comprehensive biopsychosocial intervention that can be incorporated into geriatric rehabilitation programs to promote independence, safety, and quality of life. |