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

Enhancing Recovery in Stroke Through Combined Cognitive-motor Training - a Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke Sequelae; Motor Skills Disorders
• Intervention / Treatment: Behavioral: Visuomotor force control training

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Danderyd
    • Stockholm, Danderyd, Sweden, S18288
      • Danderyd Hospital, Division of Rehabilitation Medicine, Dept. of Clinical Sciences, Karolinska Institutet
  • Stockholm
    • Danderyd, Stockholm, Sweden, SE-18288
      • Department of Rehabilitation Medicine, Danderyd Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Box and Block change (BBT change)	Assesses gross dexterity by timing how many blocks can be grasped and displaced in one minute (measured as blocks/min)	At baseline and at 3 to assess change.
Logical reasoning change (WAIS IV matrices change)	Assesses intelligence through four composite socres: verbal comprehension, perceptual reasoning, working memory and processing speed (scored from 45 to 155).	At baseline and at 3 to assess change.
Attention change (D-KEFS trail making test 1-5)	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).	[At baseline and at 3 to assess change.
Executive function change (D-KEFS FAS, D-KEFS tower)	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).	At baseline and at 3 to assess change.

Collaborators and Investigators

• Sponsor: Danderyd Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 11, 2023
• First Submitted That Met QC Criteria: October 27, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodevelopmental Disorders; Stroke; Motor Skills Disorders
• Other Study ID Numbers: COGMOS-pilotRCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No