| CTRI Number |
CTRI/2020/06/025995 [Registered on: 19/06/2020] Trial Registered Prospectively |
| Last Modified On: |
24/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effects of video games on trunk balance in stroke patients |
|
Scientific Title of Study
|
Effects of exergaming on trunk control in patients with stroke: A randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subashree T |
| Designation |
MPT students |
| Affiliation |
Nitte institute of physiotherapy |
| Address |
Nitte institute of physiotherapy, K.S hegde medical sciences complex, nitte deemed to be university,derlakatte, mangalore, dakshina kannada, Karnataka-575018, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8903208673 |
| Fax |
|
| Email |
prettyshree96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Purusotham chippala |
| Designation |
Professor |
| Affiliation |
Nitte institute of physiotherapy |
| Address |
Ground floor, Nitte institute of physiotherapy, K.S hegde medical sciences complex, nitte deemed to be university,derlakatte, mangalore, dakshina kannada, Karnataka-575018, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9916460185 |
| Fax |
|
| Email |
chippala1979@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Purusotham chippala |
| Designation |
Professor |
| Affiliation |
Nitte institute of physiotherapy |
| Address |
Ground floor, Nitte institute of physiotherapy, K.S hegde medical sciences complex, nitte deemed to be university,derlakatte, mangalore, dakshina kannada, Karnataka-575018, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9916460185 |
| Fax |
|
| Email |
chippala1979@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of physiotherapy, k.S hegde medical hospital,derlakatte, mangalore |
|
|
Primary Sponsor
|
| Name |
Nitte deemed to be university |
| Address |
Department of physiotherapy,k.S hegde hospital, derlakatte, mangalore. |
| 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 |
| Subashree T |
Justice k.S hegde charitable hospital |
Department of medicine, 4th floor, k.S hegde hospital, mangalore
Dakshina Kannada
KARNATAKA |
8903208673
prettyshree96@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional therapy |
conventional exercise like bridging, upper-lower trunk rotation, trunk flexion with rotation, unilateral pelvic bridging with single arm or leg rise, forward reach outs, lateral trunk flexion and pelvic lifts. Duration 30 minutes a day, for 4 days a week for one week or till hospital stay. |
| Intervention |
Exergaming and conventional therapy |
Using nintendo wii fit balance board and nintendo wii game box software exercise in sitting and standing performed. And conventional exercise like bridging, upper-lower trunk rotation, trunk flexion with rotation, unilateral pelvic bridging with single arm or leg rise, forward reach outs, lateral trunk flexion and pelvic lifts. Duration 30 minutes a day, for 4 days a week for one week or till hospital stay. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Trunk impairment scale scores more than 20 at the baseline are excluded
Subjects diagnosed with stroke for the first time who are hemodynamically stable(capable to follow simple commands)
The subjects should have cognitive ability above 25/30 score, according to the MMSE scale
Subjects diagnosed with hemiparesis, sub acute and chronic stroke |
|
| ExclusionCriteria |
| Details |
Subjects with hemiplegia, apraxia and perceptual disorders (hemineglect) are excluded
Subjects with cognitive, auditory and visual impaired
Subjects with global aphasia, musculoskeletal conditions and neurological disease are excluded |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Trunk impairment scale |
4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Timed up and go test |
4 week |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/08/2020 |
| Date of Study Completion (India) |
13/05/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
13/05/2021 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Stroke is one of the major causes of physical and functional disability in the adult population globally. About 50% of patients who survived from stroke have limitations. This limitation affects the patients from doing a certain activity. Where to rehabilitate for those impairments, the trunk component is considered as a heart of stroke rehabilitation. As to provide new treatment strategies by inducing the adherence level of exercise in patients, by proffer exergaming for improving their motivation and enjoyable atmosphere. Many studies have done using exergaming in many field like PD, OA, stroke for improving balance, gait etc.. Were found to be effective. But there were no studies have done to determine the effects of exergaming on trunk control in patients with stroke |