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

Stroke Sequelae Clinical Trial

— Cogmos  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06112574
• Other study ID #: COGMOS-pilotRCT
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2023
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Danderyd Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Motor Skills Disorders
• Stroke
• Stroke Sequelae

Intervention

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.

Locations

Country	Name	City	State
Sweden	Department of Rehabilitation Medicine, Danderyd Hospital	Danderyd	Stockholm
Sweden	Danderyd Hospital, Division of Rehabilitation Medicine, Dept. of Clinical Sciences, Karolinska Institutet	Stockholm	Danderyd

Sponsors (1)

Lead Sponsor	Collaborator
Danderyd Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.