Clinical trial NCT06112574: Cognitive-motor Training Post-stroke - a Pilot Randomized Controlled Trial
Official title: Enhancing Recovery in Stroke Through Combined Cognitive-motor Training - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke Sequelae
Motor Skills Disorders
Lead sponsor: Danderyd Hospital
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Fugl-Meyer Assessment change (FMA change)
timeFrame: At baseline and at 3 to assess change.
Secondary outcomes:
measure: Box and Block change (BBT change)
timeFrame: At baseline and at 3 to assess change.
measure: Logical reasoning change (WAIS IV matrices change)
timeFrame: At baseline and at 3 to assess change.
measure: Attention change (D-KEFS trail making test 1-5)
timeFrame: [At baseline and at 3 to assess change.
measure: Executive function change (D-KEFS FAS, D-KEFS tower)
timeFrame: At baseline and at 3 to assess change.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Danderyd Hospital, Division of Rehabilitation Medicine, Dept. of Clinical Sciences, Karolinska Institutet
state: Danderyd
city: Danderyd
country: Sweden
facility: Department of Rehabilitation Medicine, Danderyd Hospital
state: Stockholm
Study officials:
References: