| CTRI Number |
CTRI/2024/07/071550 [Registered on: 30/07/2024] Trial Registered Prospectively |
| Last Modified On: |
26/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Diagnostic
Preventive |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
TO STUDY THE EFFECTIVENESS OF GAME BASED BALANCE TREATMENT ON BALANCE TRAINING FORCE PLATFORM ON STATIC AND DYNAMIC BALANCE IN OLD AGE PATIENTS |
|
Scientific Title of Study
|
EFFECT OF GAME BASED BALANCE TRAINING ON FORCE PLATFORM ON STATIC STABILITY AND DYNAMIC BALANCE IN YOUNG OLD POPULATION. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sakshi Bhavsar |
| Designation |
MPT, Student |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Parul Institute of Physiotherapy, Waghodia, Vadodara 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9869245120 |
| Fax |
391670 |
| Email |
sakshibhavsar2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chaitali Shah |
| Designation |
Associate Professor, HOD |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Parul Institute of Physiotherapy, Waghodia,Vadodara 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9998107262 |
| Fax |
391670 |
| Email |
chaitali.shah@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Sakshi Bhavsar |
| Designation |
MPT, Student |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Parul Institute of Physiotherapy, Waghodia,Vadodara 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9869245120 |
| Fax |
391670 |
| Email |
sakshibhavsar2001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Sevashram Hospital, Limbda, Waghodia, Vadodara ,391760 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 |
| Sakshi Bhavsar |
Parul Sevashram Hospital, Limbda, Vadodara 391760 |
Department of physiotherapy, division- musculoskeletal and Neuro OPD , room no -20
Vadodara
GUJARAT |
9869245120
391760
sakshibhavsar2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PARUL UNIVERSITY-IECHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z048||Encounter for examination and observation for other specified reasons, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Balance Training on Game Based Force Platform |
Frequency-12 sessions for week
Intervention time -5 mins per session |
| Comparator Agent |
Traditional balance intervention |
12 sessions for 4 weeks
Time 10 minutes per session |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1)Subjects who willing to participate in study
2)Young old between 60 to 75 years of age.
3)Both male and female young old subjects.
4)Subjects who able to walk 10 min with or without assistive devices.
5)BBS (Berg Balance Scale) score more than 41.
6)MMSE more than 24 |
|
| ExclusionCriteria |
| Details |
1)The participants who are hospitalized for more than 3 months, physically frail, or have any overt conditions that were related to diminished balance, mobility, and motor functions.
2)Neurological disorders (e.g., stroke, Parkinson)
3)Cognitive impairments (e.g., mild cognitive impairment, dementia, Alzheimer’s disease)
4)Cardiovascular conditions (e.g., uncontrolled hypertension )
5)Uncotrolled diabetes
6)Visual, vestibular, and auditory impairments.
7)Joint arthroplasty or fusion, any limb amputation or surgery, and psychological problem. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| LIMITS OF STABILITY |
4weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| POMA (Performance oriented mobility assessment) |
4weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
08/08/2024 |
| 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="1"
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
|
AIM: Aim of the study is to find out the effect of game based balance training on force platform on static stability and dynamic balance in young old age geriatric population. OBJECTIVES:
1) To determine the effect of game based balance training on force platform on static stability in young old age population. 2)To determine the effect of game based balance training on force platform on dynamic balance in young old age population. NEED OF THE STUDY AND BACKGROUND: In many studies, traditional physiotherapy exercises have proved effects on balance and stability in the case of geriatric population. The physical therapy profession is progressing towards more patient centric approaches where recent techniques are used to plan the interventions. Additionally, young old age patients may find traditional physiotherapy intervention for balance training tedious or monotonous. Game based balance program training is not only preventive but also a corrective approach for risk of fall, it is also a form of re-creational activity; which can be done with interest by the patients as it is new approach for them. Carrying out this protocol in young old age would be beneficial in later on middle age & old old age stage to prevent risk of fall. From this study we intend to experiment the effectiveness of game based program training using force platform in improving balance & stability in geriatric population. Also, we intend examine its effect on young old population so that accurate dosages for the protocol can be determined and thus, this new protocol can be included in physiotherapy approach for the improvement of the static as well as dynamic balance.
PROCEDURE:Approval will be taken from the institutional ethical committee.Informed consent will be taken from patients who will meet the inclusion criteria, will be included under in this study.Pre assessment will be done using outcome measures. 4 weeks game based intervention will be given to participants using force platform - 12 sessions/ week. Post assessment using outcome measures will be done. Statistical analysis and results calculation will be done.
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