Cognitive-motor Training Post-stroke - a Pilot Randomized Controlled Trial

NCT ID: NCT06112574

Last Updated: 2023-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-31

Study Completion Date

2024-12-31

Brief Summary

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Stroke is a leading and growing cause of long-term adult disability. Up to 80% of stroke patients have impaired manual dexterity reducing their independence, return to work and quality of life. Cognitive impairment is also common after stroke and growing evidence suggests a cognitive-motor interdependence with relevance for motor recovery. Previous studies show increased cognitive-motor interference (measured in dual-task) in stroke patients and that combining motor and cognitive task training (in a dual-task) may improve motor function above that achieved by single-task training. This project addresses post-stroke dexterity impairment and its relation to dual-task interference, i.e., the decrease in motor performance when performing a concurrent cognitive task. The overall goal is to provide a proof-of-concept for a dual-task interference training protocol post-stroke. We aim to establish therapeutic efficacy of dual-task vs single-task dexterity training in chronic stroke patients.Single-task training involves visuomotor finger force tracking and dual-task has an additional cognitive components including visual distraction and working memory. Training will be done 4 days/week over four weeks (total 16 sessions). Each session will include 20 mins of conventional therapy (stretching, functional exercises) followed by 40 mins motor task training (either single or dual task). This pilot randomized clinical trial will include 40 stroke patients (\> 6 months after stroke). Repeated clinical and fine-grained motor measurements will be obtained pre and post intervention and at 3 months follow-up.

Detailed Description

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Conditions

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Stroke Sequelae Motor Skills Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Single-task

Visuomotor training

Group Type ACTIVE_COMPARATOR

Visuomotor force control training

Intervention Type BEHAVIORAL

Single-task training involves visuomotor finger force tracking and dual-task has an additional cognitive components including visual distraction and working memory.

Dual-task

Visuomotor + cognitive components training

Group Type EXPERIMENTAL

Visuomotor force control training

Intervention Type BEHAVIORAL

Single-task training involves visuomotor finger force tracking and dual-task has an additional cognitive components including visual distraction and working memory.

Interventions

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Visuomotor force control training

Single-task training involves visuomotor finger force tracking and dual-task has an additional cognitive components including visual distraction and working memory.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* adults with clinical diagnosis of stroke and history of upper limb hemiparesis. Arm and hand paresis is defined as weakness according to Manual Muscle Testing (score less than 4/5 in one upper limb muscles)
* reported difficulty in opening/closing of hand or difficulty in using the hand in daily activities

Exclusion Criteria

* inability to grasp and displace an object (minimum score of 1 on Box and Block Test, BBT)
* impaired cognition (MOCA score \<23)
* cerebellar stroke
* aphasia disturbing communication and understanding of training task
* neglect interfering with ability to see task on screen
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danderyd Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Danderyd Hospital, Division of Rehabilitation Medicine, Dept. of Clinical Sciences, Karolinska Institutet

Stockholm, Danderyd, Sweden

Site Status

Department of Rehabilitation Medicine, Danderyd Hospital

Danderyd, Stockholm County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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COGMOS-pilotRCT

Identifier Type: -

Identifier Source: org_study_id

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