| CTRI Number |
CTRI/2024/04/065643 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
08/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Behavioral |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Finding how improving walking environment encourages the stroke patients to walk in the community |
|
Scientific Title of Study
|
Influence of Mobility related Environmental Enrichment on Motivation in Stroke Survivors |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subhicha R S |
| Designation |
Postgraduate Resident |
| Affiliation |
The Oxford College of Physiotherapy |
| Address |
The Department of Neuro - Physiotherapy,No.6/9A,
1st cross, Begur road, Hongasandra, Bommanahalli
Bangalore
KARNATAKA
560068
India |
| Phone |
7395879360 |
| Fax |
|
| Email |
rssubhicha1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Senthil K |
| Designation |
Professor |
| Affiliation |
The Oxford College Of Physiotherapy |
| Address |
The Department of Neuro-Physiotherapy,No.6/9A,
1st cross, Begur road, Hongasandra, Bommanahalli
Bangalore
KARNATAKA
5600068
India |
| Phone |
8667701494 |
| Fax |
|
| Email |
k.sendil23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Vasanthan |
| Designation |
Principal |
| Affiliation |
The Oxford College of Physiotherapy |
| Address |
The Department of Neuro- Physiotherapy,No.6/9A,
1st cross, Begur road, Hongasandra, Bommanahalli
Bangalore
KARNATAKA
560068
India |
| Phone |
09916919685 |
| Fax |
|
| Email |
physiotherapyprincipal@theoxford.edu |
|
|
Source of Monetary or Material Support
|
| NATIONAL INSTITUTE OF UNANI MEDICINE, Kotiigepalya, Magadi main road, Bangalore, Karnataka, 560091 |
| The Oxford College of Physiotherapy, No.6/9, 1st cross, begur
road,Hongasandra,
Bengaluru- 560068
Bangalore
KARNATAKA |
|
|
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 |
| Dr Subhicha R S |
The Oxford College Of Physiotherapy |
Physiotherapy OPD, No.6/9A, 1st cross, Begur road,Hongasandra,Bommanahalli, Bengaluru- 560068
Bangalore
KARNATAKA |
7395879360
rssubhicha1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Oxford College of Physiotherapy Review Board for Ethics and Research |
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
|
| Type |
Name |
Details |
| Intervention |
Level 1 - Enriched Environment |
Walking intervention with 10 facilitators for 4 Weeks |
| Intervention |
Level 2 - Mildly Enriched |
Walking intervention with 7 facilitators and 3 barriers for 4 weeks |
| Intervention |
Level 3 - Moderately Enriched |
Walking intervention with 5 facilitators and 5 barriers for 4 weeks.
|
| Intervention |
Level 4 - Enriched Environment |
Walking intervention with 3 facilitators and 7 barriers for 4 weeks |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants who are diagnosed with ischemic/ hemorrhagic stroke confirmed on CT or MRI.
2. Male and Female participants.
3. Stroke survivors above 18 years of age.
4. Sub-acute and Chronic stage stroke survivor.
5. Participants who are mobile with or without assistive devices.
|
|
| ExclusionCriteria |
| Details |
1. Participants diagnosed without Neurological or Neuromuscular Disorder.
2. Participants who are with cognitive deficits i.e., MMSE score less than 18
3. Participants who are not willing to participate in the study.
• Participants with acute lower limb injury.
|
|
|
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 |
1. Determinants of Physical Activity Questionnaire
2. Self efficacy for Exercise
3. Stages of Change questionnaire
4. Intention scales
5. Perceived Barriers to Community mobility Questionnaire |
Baseline -0
Post Intervention - 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
19/04/2024 |
| 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="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
BACKGROUND : One of the most disabling outcomes of stroke has been
found as a limitation in community walking. More than 80% of stroke
patients experience walking difficulties, which ultimately restricts their
capacity to carry out everyday tasks and interact with others in the
community. Thus, identifying the environmental features and
ultimately changing the environment to be more accessible has the potential to
increase walking in the community. OBJECTIVE: To identify the influence of
environmental enrichment on motivation in stroke survivors. DESIGN : Randomised, parallel group,
multiple arm trail. SETTING :Physiotherapy department in
Stroke rehabilitation centers, Physiotherapy OPD’s and Neuro physiotherapy
clinics in Bangalore. PARTICIPANTS: 68 participants will be randomly allocated
through concealed allocation into 4 groups which is based on the levels of
enriched environment. INTERVENTION: A semi-standardized
interview will be conducted for 68 participants. Interviews with participants
will be tape recorded, audio files will be transcribed verbatim. Pre-
assessment will be done using scales. The facilitators and barriers for each
participant will be noted from the interview. Based upon the groups, they
are in, intervention will be provided for 4 weeks using “Action
Statementâ€. 4 week- intervention programme will be given for 40 minutes, 5
days per week. Post-
assessment will be done after 4 weeks of intervention using outcome measures. MAIN
OUTCOME MEASURES : The Primary Outcome Measures will measure the levels of
motivation using self report questionnaires at baseline and post intervention.
The following outcome measures will be used : Determinants of Physical Activity
Questionnaire (DPAQ), Self Efficacy for Exercise (SEE), Stages of Change
Questionnaire and Intentional scales. These questionnaires will be
translated into community mobility. DATA
ANALYSIS : The data collected between group analysis will be done
using Mann-Whitney U Test to find out whether enrichment changes motivation
levels in patients |