NCT07208422

Brief Summary

The goal of this pilot RCT is to evaluate the effectiveness of a Task-specific Self-rehabilitation Training (TASSRET) program and compare the effect of the two formats of the TASSRET (video vs manual) on functional ability (upper extremity fine and gross motor skills, upper extremity manual dexterity and speed, voluntary movement and basic mobility, gait velocity, balance) and health-related quality of life among Hausa-native stroke survivors. The main questions it aims to answer are:

  1. 1.What is the immediate effect and durability of TASSRET on functional ability (upper extremity fine and gross motor skills, upper extremity manual dexterity and speed, voluntary movement and basic mobility, gait velocity, balance) and health-related quality of life among the Hausa-native stroke survivors?
  2. 2.Which of the self-rehabilitation formats (TASSRET-manual or TASSRET-video) is more effective (immediate and durable) at improving functional ability (upper extremity fine and gross motor skills, upper extremity manual dexterity and speed, voluntary movement and basic mobility, gait velocity, balance) and health-related quality of life among the Hausa-native stroke survivors?

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 7, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 6, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

September 27, 2025

Last Update Submit

December 13, 2025

Conditions

Keywords

Stroke rehabilitationTask-specific TrainingLMICsSelf-administered interventionFunctional ability

Outcome Measures

Primary Outcomes (6)

  • Action Research Arm Test (ARAT)

    This is a measure of upper extremity fine and gross motor skills. The scale ranges from 0 to 57, with higher scores indicating better upper extremity fine and gross motor skills.

    Baseline, six weeks post-intervention and three-month follow-up.

  • Stroke Rehabilitation Assessment of Movement (STREAM)

    A measure of voluntary movement and basic mobility. The scale ranges from o to 100, with higher scores indicating better voluntary movement and basic mobility.

    Baseline, six weeks post-intervention and three-month follow-up.

  • Box and Block Test (BBT)

    This measure manual dexterity and speed. The assessment is based on the number of blocks transferred from one compartment to the other within one minute. Higher scores indicate better manual dexterity and speed.

    Baseline, six weeks post-intervention and three-month follow-up.

  • Ten-Meter Walk Test (10MWT)

    A measure of gait velocity. This is the time taken to walk a distance of ten meters, it is reported in meter per second. Lower scores indicate better gait velocity.

    Baseline, six weeks post-intervention and three-month follow-up.

  • Mini-Balance Evaluation System Test (Mini-BEST)

    This is a measure of dynamic balance. The scores range from 0 to 28, with higher scores indicating better dynamic balance.

    Baseline, six weeks post-intervention and three-month follow-up.

  • Stroke Impact Scale (SIS)

    A self-reported measure of health-related quality of life. The scores range from 0 to 100, with higher scores indicating better perceived health-related quality of life.

    Baseline, six weeks post-intervention and three-month follow-up.

Secondary Outcomes (2)

  • Modified Ashworth scale (MAS)

    Baseline, six weeks post-intervention and three-month follow-up.

  • Manual Muscle Testing (MMT)

    Baseline, six weeks post-intervention and three-month follow-up.

Other Outcomes (1)

  • Adverse event

    Six weeks post-intervention and three-month follow-up.

Study Arms (2)

TASSRET-video

EXPERIMENTAL

Participants in this group will use the TASSRET-video, which will be transferred to their phones via Xender (a file-sharing app). The application is user-friendly and features video clips of individuals demonstrating task training, accompanied by verbal explanations in Hausa. Upon opening the app, participants first view an introductory video on how to use the application. They can then navigate through three main sections: training for upper extremity function, training for lower extremity and balance function, and training for trunk strength. Each section starts with an instructional video. Participants will be required to select training sessions based on their rehabilitation needs, follow the videos, and perform the tasks, starting with ten repetitions or more (depending on comfort) per session. The number of repetitions is to be increased by at least 50% weekly, not exceeding a maximum of 300 repetitions per session. The training will be performed twice daily, three times per wee

Behavioral: Video-based Task-specific Training

TASSRET-manual

ACTIVE COMPARATOR

2\. TASSRET-manual: Participants in this group will be given the TASSRET-manual, which contains the same task training as the video version. The manual covers pictures of individuals demonstrating the tasks with a corresponding text description in the Hausa language. Participants will be instructed to follow the images and text descriptions to perform the tasks, mirroring the training process in the video group. The frequency, number of repetitions, and duration of the intervention are the same as in the TASSRET-video group.

Behavioral: Manual-based Task-specific Training

Interventions

Video-based self-administered TST

Also known as: Video-based TST
TASSRET-video

Manual-based self-administered TST

Also known as: Manual-based TST
TASSRET-manual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Are aged 18 years or older
  • Diagnosed with a first-ever episode of ischemic or haemorrhagic stroke (including intracerebral haemorrhage and subarachnoid haemorrhage)
  • Speaks and understands the Hausa language
  • Living within the community and having no access to physiotherapy care
  • Having access to an Android phone
  • More than 10-degree extension of the index finger and abduction of the thumb
  • Cognitive ability to follow commands, as indicated by a score of 0 to 1 on the Commands item of the National Institutes of Health Stroke Scale or a Mini-Mental State Examination score of ≥24
  • Ability to stand and take a step (with or without support).

You may not qualify if:

  • Had cerebrovascular events due to malignancy or head trauma
  • Had been diagnosed with other neurological disorders
  • Were not permanent residents of the selected communities
  • Were currently receiving any form of physical rehabilitation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kura, Karfi and Dan-Hassan communities

Kano, 711101, Nigeria

RECRUITING

Related Publications (1)

  • Ibrahim R, Joseph C, Stewart A, Lawal IU. Self-rehabilitation strategy for rural community-dwelling stroke survivors in a lower-middle income country: a modified Delphi study. PLoS One. 2025 Feb 25;20(2):e0303658. doi: 10.1371/journal.pone.0303658. eCollection 2025.

    PMID: 39999052BACKGROUND

Related Links

MeSH Terms

Conditions

StrokeHemorrhagic StrokeIschemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Rabiu Ibrahim, MSc

    National Assembly Clinic

    PRINCIPAL INVESTIGATOR
  • Isa U Lawal, PhD

    Bayero University Kano, Nigeria

    STUDY CHAIR

Central Study Contacts

Rabiu Ibrahim, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Stattitician
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Physiotherapy

Study Record Dates

First Submitted

September 27, 2025

First Posted

October 6, 2025

Study Start

June 7, 2025

Primary Completion

December 1, 2025

Study Completion

February 1, 2026

Last Updated

December 19, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

The results of the study will be published and be presented in scientific conferences

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
At the end of the study (sometimes in November 2025)
Access Criteria
The Raw data (anonymized) can be accessed from the principal investigator on request.

Locations