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

Sponsor
Danderyd Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06112574
Collaborator
(none)
40
2
2
14
20
1.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Visuomotor force control training
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Enhancing Recovery in Stroke Through Combined Cognitive-motor Training - a Randomized Controlled Trial
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Single-task

Visuomotor training

Behavioral: 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.

Experimental: Dual-task

Visuomotor + cognitive components training

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Fugl-Meyer Assessment change (FMA change) [At baseline and at 3 to assess change.]

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

Secondary Outcome Measures

  1. Box and Block change (BBT change) [At baseline and at 3 to assess change.]

    Assesses gross dexterity by timing how many blocks can be grasped and displaced in one minute (measured as blocks/min)

  2. Logical reasoning change (WAIS IV matrices change) [At baseline and at 3 to assess change.]

    Assesses intelligence through four composite socres: verbal comprehension, perceptual reasoning, working memory and processing speed (scored from 45 to 155).

  3. Attention change (D-KEFS trail making test 1-5) [[At baseline and at 3 to assess change.]

    Trail making test assesses attention capacites in five conditions: visual scanning, number sequencing, letter sequencing, number-letter sequencing, and motor speed (the speed of each condition is noted in seconds, max 150seconds).

  4. Executive function change (D-KEFS FAS, D-KEFS tower) [At baseline and at 3 to assess change.]

    Assesses executive function capacities such as spatial planning, rule learning, inhibition of impulsive responding, inhibition of perseverative responding, and establishing and maintaining instructional set. Scoring: raw scores are converted to scaled scores through established age and gender normative data, Mean=10, standard deviation=3).

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Danderyd Hospital, Division of Rehabilitation Medicine, Dept. of Clinical Sciences, Karolinska Institutet Stockholm Danderyd Sweden S18288
2 Department of Rehabilitation Medicine, Danderyd Hospital Danderyd Stockholm Sweden SE-18288

Sponsors and Collaborators

  • Danderyd Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Danderyd Hospital
ClinicalTrials.gov Identifier:
NCT06112574
Other Study ID Numbers:
  • COGMOS-pilotRCT
First Posted:
Nov 1, 2023
Last Update Posted:
Nov 1, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 1, 2023