Strategy Training for Stroke Survivors

Overseen By Elizabeth Skidmore, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Haifa

Disqualifiers: Dementia, Severe aphasia, CNS disorder, others

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

Compensation: Varies

Number of Visits: 10

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how strategy training, also known as Metacognitive Strategy Training, can help stroke survivors improve their thinking skills and engage more in their communities. The study will examine two groups: stroke survivors living with pets and those without pets, to determine if having a pet influences recovery. Participants will receive strategy training sessions at home, guided by an occupational therapist. Stroke survivors who experienced a stroke more than three months ago and live in the community may be suitable candidates, particularly if they face challenges with thinking or participating in daily activities. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance recovery strategies for stroke survivors.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that strategy training is safe for stroke survivors?

Research shows that strategy training is generally safe for people who have had a stroke. Studies have not identified any specific safety issues with this method. Previous research indicates that individuals handle strategy training well during their recovery. Participants reported no major negative effects. Overall, strategy training appears to be a safe way to help improve thinking skills after a stroke. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about strategy training for stroke survivors because it offers a personalized approach to rehabilitation that focuses on teaching practical strategies to overcome daily challenges. Unlike traditional therapies that often concentrate on specific physical or cognitive exercises, strategy training empowers survivors by helping them develop problem-solving skills tailored to their unique situations. This method is particularly promising because it can be delivered conveniently at home, potentially improving adherence and outcomes for individuals with varying levels of mobility. Additionally, the trial is exploring whether having a pet influences the effectiveness of this training, opening new avenues for understanding the role of companionship in recovery.

What evidence suggests that strategy training is effective for stroke survivors?

This trial will compare the effects of strategy training for stroke survivors with and without pets. Research has shown that strategy training can aid stroke recovery. Studies have found it boosts productivity and increases social activity involvement. Participants in these studies have made noticeable progress in rehabilitation and gained independence in daily tasks. Early evidence suggests that strategy training might reduce disability within the first six months after a stroke. Overall, it appears promising in improving activity performance and reducing movement difficulties. ^{1 3 4 6 7}

Who Is on the Research Team?

Naor Domotor, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for adult stroke survivors who are at least 3 months post-stroke, experiencing reduced activity levels and some cognitive impairment. Participants must live with a pet, be willing to undergo a 6-week home-based program with two sessions weekly, and have had a primary diagnosis of acute stroke.

Inclusion Criteria

It has been over 3 months since I had a stroke.

You are not able to do at least 80% of the activities you used to do before having a stroke, as determined by an Activity Card Sort.

You live in a shared living space with a pet.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive strategy training for 10-15 sessions, 45 minutes each session, delivered by a trained occupational therapist in the home

6 weeks

10-15 visits (in-person)

Follow-up

Participants are monitored for changes in community participation, executive function, and attention

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Strategy Training

Trial Overview The study is testing 'strategy training' to see if it helps improve cognitive performance and community involvement in stroke survivors. It will also explore whether having pets affects the outcomes of this intervention.

How Is the Trial Designed?

Group I: Stroke survivors with pets Experimental Treatment 1 Intervention

Stroke survivors with pets will receive strategy training for 10-15 sessions, 45 minutes each session, delivered by a trained occupational therapist in the home.

Group II: Stroke survivors without pets Active Control 1 Intervention

Stroke survivors without pets will receive strategy training for 10-15 sessions, 45 minutes each session, delivered by a trained occupational therapist in the home.

Who Is Running the Clinical Trial?

University of Haifa

Lead Sponsor

Trials

126

Recruited

22,200+

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Published Research Related to This Trial

Meta-cognitive strategy training, specifically the CO-OP method, was successfully implemented during inpatient rehabilitation for a patient with cognitive impairments after a right hemisphere stroke, showing its feasibility in a clinical setting.

The participant demonstrated significant improvements in rehabilitation engagement and functional independence, with notable increases in performance scores across various measures, suggesting potential benefits of this training approach for stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility of meta-cognitive strategy training in acute inpatient stroke rehabilitation: case report. Skidmore, ER., Holm, MB., Whyte, EM., et al.[2021]

A pilot study involving 10 adults with stroke-related cognitive impairments showed that strategy training, when added to usual rehabilitation care, is feasible and well-accepted, with high participant retention and satisfaction rates.

Participants who received strategy training demonstrated significantly less disability at six months compared to those who received an attention control session, suggesting that this approach may effectively enhance recovery in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing complex interventions: lessons learned from a pilot study examining strategy training in acute stroke rehabilitation. Skidmore, ER., Dawson, DR., Whyte, EM., et al.[2021]

In a study of 44 chronic stroke survivors, adding cognitive strategy training to task-specific training (COSTAR) did not show significant benefits over traditional task-specific training (TST) in improving activity and participation outcomes, despite both groups showing some improvement.

The high attrition rate in the COSTAR group (50%) compared to the TST group (25%) may have influenced the results, suggesting that while cognitive strategies could enhance generalization of skills, their immediate impact on activity performance was not evident in this trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive oriented strategy training augmented rehabilitation (COSTAR) for ischemic stroke: a pilot exploratory randomized controlled study. Wolf, TJ., Doherty, M., Boone, A., et al.[2022]

An adapted metacognitive strategy training protocol for 16 adults with mild to moderate aphasia was found to be feasible in an inpatient stroke rehabilitation setting, with therapists delivering the intervention effectively.

Participants showed significant improvement in disability, achieving a mean change of 21.8 on the Functional Independence Measure, comparable to results from previous trials involving individuals without aphasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metacognitive Strategy Training Is Feasible for People With Aphasia. Kersey, J., Evans, WS., Mullen, K., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04099511

Metacognitive-Strategy Training in Sub-Acute Stroke The long-term goal of this research is to improve activity performance and reduce motor impairment in individuals with stroke.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4465421/

Strategy training shows promise for addressing disability in ... Strategy training shows promise for addressing disability in the first 6 months after stroke. Lessons from this pilot study may inform future clinical trials.

3. ahajournals.org ahajournals.org/doi/10.1161/JAHA.125.042295

Enhancing Societal Participation for Stroke Survivors With ... Participation‐focused strategy training significantly improved productivity and social participation among enrolled stroke survivors compared ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3072282/

A Case Report Examining the Feasibility of Meta-Cognitive ... The results indicate that meta-cognitive strategy training was feasible during inpatient rehabilitation and warrants further evaluation to determine its ...

5. withpower.com withpower.com/trial/phase-stroke-11-2021-d1638

Strategy Training for Stroke Survivors · Info for Participants The participant demonstrated significant improvements in rehabilitation engagement and functional independence, with notable increases in performance scores ...

6. researchgate.net researchgate.net/publication/50353089_The_feasibility_of_meta-cognitive_strategy_training_in_acute_inpatient_stroke_rehabilitation_Case_report

(PDF) The feasibility of meta-cognitive strategy training in ... The results indicate that meta-cognitive strategy training was feasible during inpatient rehabilitation and warrants further evaluation to determine its ...

7. research.aota.org research.aota.org/ajot/article/73/3/7303345020p1/6579/Effect-of-Strategy-Training-on-Self-Awareness-of

Effect of Strategy Training on Self-Awareness of Deficits After ... The objectives of this study were to determine whether client self-awareness of deficits improves over time after stroke and whether ...