Rehabilitation Methods for Stroke Recovery

Recruiting at 4 trial locations

Overseen By Joyce L Chen, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Toronto

Disqualifiers: Neurological disorders, Cognitive deficits, Apraxia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to compare two rehabilitation methods to improve finger movements in people who have had a stroke. The main question it aims to answer is which of these two training methods leads to the most improvement: 1. Teaching people to reach their movement goals using any strategies they like. 2. Teaching people to improve their movement technique and avoid compensatory strategies. There is no one-size-fits-all approach. The second goal is to find out who might benefit more from each method. Some people with stroke may rely on compensatory strategies due to severe impairment, while others with milder strokes might benefit more from techniques that enhance movement quality. The third goal is to take pictures of the brain to see how it changes with each method. This will help researchers understand how the brain adapts after a stroke and could lead to treatments that target the brain directly. Participants will: 1. Visit the lab for clinical and research assessments on weeks 1, 4, 5, and 15. 2. Complete 10 days of piano training. 3. Undergo magnetic resonance imaging (MRI) scans twice, once in week 1 and once in week 4.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the rehabilitation method for stroke recovery safe for humans?

Research shows that exercise and mobilization after a stroke can be safe if done carefully. Guidelines suggest screening patients before starting and using strategies to prevent issues like blood pooling and low blood flow to the brain. These precautions help ensure safety during recovery. ^{1 2 3 4 5}

How does the Goal Training, Quality Training treatment for stroke recovery differ from other treatments?

The Goal Training, Quality Training treatment is unique because it emphasizes patient-centered goal setting and action planning, which involves the patient actively in their rehabilitation process. This approach is guided by the G-AP framework, which has been found to be feasible and clinically useful, focusing on personalized goals and improving the quality of rehabilitation outcomes. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Goal Training, Quality Training for stroke recovery?

Research shows that setting specific goals in stroke rehabilitation can improve the intensity of practice and help patients achieve better outcomes. Additionally, using goal attainment scaling (GAS) in intensive rehabilitation has been found useful during the subacute stage of stroke recovery. ^{6 9 11 12 13}

Who Is on the Research Team?

Joyce L Chen, PhD

Principal Investigator

University of Toronto: Faculty of Kinesiology & Physical Education

Are You a Good Fit for This Trial?

This trial is for individuals who have experienced a stroke and are working on improving hand and finger movements. Participants will need to commit to multiple lab visits, piano training sessions, and MRI scans. Specific details about inclusion or exclusion criteria were not provided.

Inclusion Criteria

I had a stroke for the first time between 6 months and 2 years ago.

I am over 18 years old.

I can move my fingers actively.

Exclusion Criteria

History of developmental, neurological, or major psychiatric disorders

I have had a stroke in the cerebellum.

Contraindications to MRI

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo initial clinical and research assessments, including MRI scans

1 week

1 visit (in-person)

Piano Training

Participants complete 10 days of piano training, focusing on either quality of movement or achieving movement goals

2 weeks

10 visits (in-person)

Post-training Assessment

Participants undergo post-training assessments, including MRI scans and clinical evaluations

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after training, with assessments at 3 months

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Goal Training
• Quality Training

Trial Overview The study compares two rehabilitation methods: Goal Training, which allows any strategy to reach movement goals, and Quality Training, which focuses on technique improvement without compensatory strategies. It also examines brain changes through MRI imaging.

How Is the Trial Designed?

Group I: Quality Training Group Active Control 1 Intervention

Group II: Goal Training Group Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

Heart and Stroke Foundation of Canada

Collaborator

Trials

131

Recruited

72,600+

McGill University

Collaborator

Trials

421

Recruited

1,017,000+

Published Research Related to This Trial

In a study of 200 patients with moderate to severe subacute stroke, those who underwent aerobic training experienced a higher rate of serious adverse events compared to those in the relaxation control group, with an incident rate ratio of 1.70.

The occurrence of serious adverse events in the aerobic training group was significantly influenced by pre-existing conditions such as diabetes mellitus and atrial fibrillation, indicating that these factors may increase risk and warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Fitness Training in Patients with Subacute Stroke (PHYS-STROKE): Safety analyses of a randomized clinical trial. Rackoll, T., Nave, AH., Ebinger, M., et al.[2022]

This review provides evidence-based guidelines for safely implementing aerobic exercise in the early phases post-stroke, emphasizing the importance of pre-participation screening and monitoring for potential complications like blood pressure dysregulation and cerebral hypoperfusion.

Countermeasures such as avoiding prolonged standing and incorporating lower limb movements are recommended to prevent blood pooling and minimize risks during exercise, ensuring a safer rehabilitation process for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerobic Training and Mobilization Early Post-stroke: Cautions and Considerations. Marzolini, S., Robertson, AD., Oh, P., et al.[2020]

A systematic review of 37 randomized controlled trials (RCTs) found that while most studies reported the principle of specificity in exercise training for stroke survivors, only 13.5% included all key training principles, which limits the effectiveness of exercise interventions.

Patient adherence to prescribed exercise regimens was poorly reported, with only 8.1% of studies accounting for it, highlighting a significant gap in ensuring that stroke survivors follow through with their exercise programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of principles of exercise training in sub-acute and chronic stroke survivors: a systematic review. Ammann, BC., Knols, RH., Baschung, P., et al.[2022]

A randomized controlled trial with 33 chronic stroke patients showed that a 4-week treadmill training program significantly improved gait velocity and dynamic balance ability compared to traditional training, indicating its effectiveness for rehabilitation.

The study found no adverse effects from the training, suggesting that challenging treadmill speed-dependent gait and balance training is a safe and feasible option for stroke patients with low ambulation ability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of challenging treadmill speed-dependent gait and perturbation-induced balance training in chronic stroke patients with low ambulation ability: a randomized controlled trial. Hu, J., Jin, L., Wang, Y., et al.[2023]

Citations

1. England pubmed.ncbi.nlm.nih.gov

The effects and experiences of goal setting in stroke rehabilitation - a systematic review. [2022]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Usefulness of Goal Attainment Scaling in Intensive Stroke Rehabilitation During the Subacute Stage. [2020]

3. Australia pubmed.ncbi.nlm.nih.gov

Motor assessment scale scores as a measure of rehabilitation outcome following stroke. [2014]

4. United States pubmed.ncbi.nlm.nih.gov

Stroke rehabilitation. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Goal-oriented instructions increase the intensity of practice in stroke rehabilitation compared with non-specific instructions: a within-participant, repeated measures experimental study. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Physical Fitness Training in Patients with Subacute Stroke (PHYS-STROKE): Safety analyses of a randomized clinical trial. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Aerobic Training and Mobilization Early Post-stroke: Cautions and Considerations. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Obstacle avoidance training for individuals with stroke: a systematic review and meta-analysis. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Application of principles of exercise training in sub-acute and chronic stroke survivors: a systematic review. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility of challenging treadmill speed-dependent gait and perturbation-induced balance training in chronic stroke patients with low ambulation ability: a randomized controlled trial. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Facilitators and "deal breakers": a mixed methods study investigating implementation of the Goal setting and action planning (G-AP) framework in community rehabilitation teams. [2023]

12. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Functional and activity limitations in patients after a stroke]. [2022]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Stroke rehabilitation: clinical picture, assessment, and therapeutic challenge. [2022]