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Cognitive-motor Training Post-stroke - a Pilot Randomized Controlled Trial (Cogmos)

D

Danderyd Hospital

Status

Not yet enrolling

Conditions

Stroke Sequelae
Motor Skills Disorders

Treatments

Behavioral: Visuomotor force control training

Study type

Interventional

Funder types

Other

Identifiers

NCT06112574
COGMOS-pilotRCT

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

Single-task
Active Comparator group
Description:
Visuomotor training
Treatment:
Behavioral: Visuomotor force control training
Dual-task
Experimental group
Description:
Visuomotor + cognitive components training
Treatment:
Behavioral: Visuomotor force control training

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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