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

NCT06112574 | Unknown

• 1 other identifier: COGMOS-pilotRCT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Stroke Sequelae; Motor Skills Disorders

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment change (FMA change)

  Assesses sensory and movement related functions in the upper extremity (0 points max impairment summed up to 66 points max no detected impairment)

  At baseline and at 3 to assess change.

Secondary Outcomes (4)

• Box and Block change (BBT change)

  At baseline and at 3 to assess change.

• Logical reasoning change (WAIS IV matrices change)

  At baseline and at 3 to assess change.

• Attention change (D-KEFS trail making test 1-5)

  [At baseline and at 3 to assess change.

• Executive function change (D-KEFS FAS, D-KEFS tower)

  At baseline and at 3 to assess change.

Study Arms (2)

Single-task

ACTIVE COMPARATOR

Visuomotor training

Behavioral: Visuomotor force control training

Dual-task

EXPERIMENTAL

Visuomotor + cognitive components training

Behavioral: Visuomotor force control training

Interventions

Visuomotor force control training 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; Single-task

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Danderyd Hospital: lead

Study Sites (2)

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

Stockholm, Danderyd, S18288, Sweden

Location

Department of Rehabilitation Medicine, Danderyd Hospital

Danderyd, Stockholm County, SE-18288, Sweden

Location

MeSH Terms

Conditions

Motor Skills Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: November 1, 2023
• Study Start: October 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)