CTRI Number |
CTRI/2025/05/086833 [Registered on: 13/05/2025] Trial Registered Prospectively |
Last Modified On: |
13/05/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Physiotherapy (Not Including YOGA) |
Study Design |
Randomized, Crossover Trial |
Public Title of Study
|
A study to compare two different learning methods to see which helps adult long term stroke survivors to walk better while doing a counting task |
Scientific Title of Study
|
Comparison between immediate effects of implicit and explicit motor learning strategies in gait cognitive dual task among adult chronic stroke survivors- A crossover 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 |
Bhakti Somani |
Designation |
Postgraduate Student-MPT |
Affiliation |
All India Institute of Physical Medicine and Rehabilitation |
Address |
Department of physiotherapy, All India Institute of Physical Medicine and Rehabilitation, Haji Ali Dargah, Keshavrao Khadye Marg, Haji Ali Government Colony, Mahalakshmi, Mumbai, Maharashtra 400034
Mumbai MAHARASHTRA 400034 India |
Phone |
9834925758 |
Fax |
|
Email |
bhaktisomani07@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Anitha Kumaravelan |
Designation |
Lecturer |
Affiliation |
All India Institute of Physical Medicine and Rehabilitation |
Address |
Department of physiotherapy, All India Institute of Physical Medicine and Rehabilitation, Haji Ali Dargah, Keshavrao Khadye Marg, Haji Ali Government Colony, Mahalakshmi, Mumbai, Maharashtra 400034
Mumbai MAHARASHTRA 400034 India |
Phone |
9820285788 |
Fax |
|
Email |
anithakumaravelan@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Bhakti Somani |
Designation |
Postgraduate Student-MPT |
Affiliation |
All India Institute of Physical Medicine and Rehabilitation |
Address |
Department of physiotherapy, All India Institute of Physical Medicine and Rehabilitation, Haji Ali Dargah, Keshavrao Khadye Marg, Haji Ali Government Colony, Mahalakshmi, Mumbai, Maharashtra 400034
Mumbai MAHARASHTRA 400034 India |
Phone |
9834925758 |
Fax |
|
Email |
bhaktisomani07@gmail.com |
|
Source of Monetary or Material Support
|
Department of Physiotherapy All India Institute of Physical Medicine and Rehabilitation, Haji Ali Dargah, Keshavrao Khadye Marg, Haji Ali Government Colony, Mahalakshmi, Mumbai, Maharashtra, India 400034 |
|
Primary Sponsor
|
Name |
All India Institute of Physical Medicine and Rehabilitation |
Address |
Department of Physiotherapy, All India Institute of Physical Medicine and Rehabilitation,Haji Ali Dargah, Keshavrao Khadye Marg, Haji Ali Government Colony, Mahalakshmi, Mumbai, Maharashtra, India 400034 |
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 Bhakti Somani PT |
AIIPMR,KK Marg, Haji Ali Government Colony, Mahalakshmi, Mumbai, Maharashtra, India 400034 |
Room no.207, Adult Neuromotor Training Section, Department of Physiotherapy Mumbai MAHARASHTRA |
9834925758
bhaktisomani07@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Ethics Committee, AIIPMR |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:I699||Sequelae of unspecified cerebrovascular diseases. Ayurveda Condition: PAKSHAGHATA/PAKSHAVADHAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | Implicit and Explicit Motor Learning | (Procedure Reference: , Procedure details: Participants will undergo dual-task gait training on a figure-of-eight path while counting tones. The training includes one practice block, five learning blocks (three sessions each), and a final re-enactment stage to assess gait. Group A will receive implicit training first, followed by explicit training with an interval of 48 hours, while Group B will follow the reverse order.
)
|
|
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Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1.Unilateral Hemiparesis or Hemiplegia occurring for the first time after a CVA with duration of at least 6 months since onset.
2.Individuals walking independently with or without help of assistive device with speed of more than or equal to 0.4m per second.
3.Age-18-60 years.
4.Individuals with MMSE score more than 24.
|
|
ExclusionCriteria |
Details |
1.Individuals having any other neurological or musculoskeletal or cardiopulmonary clinical manifestations that could affect gait performance. |
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Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Pre-numbered or coded identical Containers |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Figure of 8 walking test |
Baseline( Day 1), After first intervention on the same day (Day 1), After washout period of 48 hours post second intervention (Day 4) |
|
Secondary Outcome
|
Outcome |
TimePoints |
Not Applicable |
Not Applicable |
|
Target Sample Size
|
Total Sample Size="18" Sample Size from India="18"
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 3 |
Date of First Enrollment (India)
|
24/05/2025 |
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="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
|
Stroke is a leading cause of adult disability worldwide, commonly resulting in motor and cognitive impairments that significantly hinder daily activities, particularly dual tasks like talking while walking. Dual-task training is essential in stroke rehabilitation as it targets both motor and cognitive challenges, improving functional independence, community participation, and quality of life. Gait training is a key rehabilitation focus, though even after regaining walking ability, patients remain vulnerable to interference during multitasking. Motor learning which is critical in stroke recovery occurs in three phases: acquisition, consolidation, and retention, with different brain regions involved in each phase. Stroke-related brain damage affects these phases differently but may be mitigated by neural compensation. Two motor learning strategies-explicit (conscious, instruction-based) and implicit (automatic, unconscious) offer tailored approaches. While both methods can improve motor tasks, it’s still unclear which is more effective for dual-task situations. There is limited research comparing these approaches in real-life tasks as most studies have been done in non clinical tasks such as serial reaction time task. This study is aims to find out which learning strategy works best for improving dual-task performance of gait cognitive dual task after stroke, helping to guide better rehabilitation. Methodology- This is a crossover experimental study. 18 participants who meet the selection criteria will participate in the study. Convenience sampling and then random allocation will be done. Pre training dual task measurement will be done for all participants. Each group will have nine participants. Group A will receive implicit training first, followed by explicit training after 48 hours, while Group B will follow the reverse order. All participants will undergo both types of training, with the sequence depending on their group assignment. Post training dual task measurement will be done. Statistical analysis-Statistical analysis will be conducted at a 95% confidence level, with significance set at P < 0.05. Data normality will be assessed using the Shapiro-Wilk test; if normal, a paired t-test will be used, otherwise the Wilcoxon signed-rank test will be applied.
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