Stroke SequelaeCogmosNCT06112574
Cognitive-motor Training Post-stroke - a Pilot Randomized Controlled Trial
A study of Stroke Sequelae and Motor Skills Disorders, run by Danderyd Hospital at 2 sites in Sweden.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke Sequelae, Motor Skills Disorders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesSweden
- Study dates
- Oct 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Department of Rehabilitation Medicine, Danderyd Hospital
Danderyd, Stockholm County, SE-18288
Danderyd Hospital, Division of Rehabilitation Medicine, Dept. of Clinical Sciences, Karolinska Institutet
Stockholm, Danderyd, S18288
About this study
Official title: 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.
- Conditions
- Stroke Sequelae, Motor Skills Disorders
- Being tested
- Visuomotor force control training
- Medical subject headings
- Motor Skills Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visuomotor force control trainingBehavioural
Single-task training involves visuomotor finger force tracking and dual-task has an additional cognitive components including visual distraction and working memory.
| Study group | Role | What they receive |
|---|---|---|
| Single-task | Active comparator | Visuomotor training Receives: Behavioral: Visuomotor force control training |
| Dual-task | Experimental | Visuomotor + cognitive components training Receives: Behavioral: Visuomotor force control training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At baseline and at 3 to assess change.
Secondary outcomes (4)
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)
Measured: 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).
Measured: 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).
Measured: [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).
Measured: At baseline and at 3 to assess change.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study startOct 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke SequelaeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danderyd Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112574
- Sponsor's protocol ID
- COGMOS-pilotRCT
- Acronym
- Cogmos
- Status last verified
- Oct 2023
- First submitted
- 11 Sep 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Recovery in Stroke Through Combined Cognitive-motor Training - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06112574
- Acronym / sponsor ID
- Cogmos / COGMOS-pilotRCT
- Conditions
- Stroke Sequelae, Motor Skills Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Danderyd HospitalUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-task | Active comparator | Behavioral: Visuomotor force control trainingVisuomotor training |
| Dual-task | Experimental | Behavioral: Visuomotor force control trainingVisuomotor + cognitive components training |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visuomotor force control trainingSingle-task training involves visuomotor finger force tracking and dual-task has an additional cognitive components including visual distraction and working memory. | Behavioural | Dual-task, Single-task |
Primary outcome
Fugl-Meyer Assessment change (FMA change)
Time frame: 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)
4 secondary outcomes
Box and Block change (BBT change)
Time frame: At baseline and at 3 to assess change.
Logical reasoning change (WAIS IV matrices change)
Time frame: At baseline and at 3 to assess change.
Attention change (D-KEFS trail making test 1-5)
Time frame: [At baseline and at 3 to assess change.
Executive function change (D-KEFS FAS, D-KEFS tower)
Time frame: At baseline and at 3 to assess change.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Stroke Sequelae and Motor Skills Disorders, run by Danderyd Hospital at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment change (FMA change) (time frame: At baseline and at 3 to assess change.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.