Cognitive Rehabilitation + Occupational Therapy for Stroke

Overseen By Stephanie Aghamoosa, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Moderate-severe aphasia, impaired decision making

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

Compensation: Varies

Number of Visits: 23

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether combining cognitive rehabilitation with occupational therapy (OT) can improve recovery for stroke survivors. It aims to determine if this approach enhances thinking skills, daily arm use, and overall mood and quality of life. Participants will join an 8-week program with online sessions focusing on mental exercises and arm/hand therapy. This trial suits individuals who had a stroke at least 30 days ago and have weakness in one arm or hand. Participants must speak and read English and have internet access for the online sessions. As an unphased trial, this study offers a unique opportunity to explore innovative recovery methods and contribute to advancing stroke rehabilitation.

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.

What prior data suggests that this intervention is safe for stroke survivors?

Research has shown that both cognitive rehabilitation and occupational therapy are generally safe for people recovering from a stroke. These treatments can enhance thinking skills and daily activities without causing serious side effects. Occupational therapy often plays a role in stroke recovery, aiding individuals in resuming everyday tasks.

Cognitive rehabilitation involves exercises and strategies to improve memory and thinking skills. It has been used successfully with stroke patients and is well-tolerated. Studies have not identified any major negative effects from these therapies.

However, each person's experience may vary. Consulting healthcare professionals about any concerns before starting a new treatment is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about combining cognitive rehabilitation with occupational therapy for stroke recovery because it offers a new way to deliver comprehensive care directly to patients at home through telerehabilitation. Unlike traditional therapies that often require in-person visits, this approach allows for flexibility and accessibility, which can be particularly beneficial for patients with mobility challenges. The structured program focuses on both cognitive and physical aspects of recovery, potentially enhancing overall outcomes by integrating cognitive exercises with practical, everyday skills. This dual-focus approach could lead to more holistic and sustained improvements in patients' daily lives compared to standard, separate treatments.

What evidence suggests that this trial's treatments could be effective for stroke rehabilitation?

This trial will evaluate the combination of cognitive rehabilitation and occupational therapy for stroke patients. Research has shown that these therapies together can improve thinking skills and performance in daily activities, making everyday tasks more manageable for patients. Specifically, cognitive rehabilitation aids memory, focus, and problem-solving, while occupational therapy improves arm and hand use, crucial for regaining independence. Overall, this combination aims to enhance both physical abilities and the quality of life for stroke survivors. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for stroke survivors who can participate in an 8-week tele-rehabilitation program aimed at improving cognition, daily functioning, and mood. Participants should be able to engage in cognitive rehabilitation and occupational therapy sessions.

Inclusion Criteria

I had a stroke that weakened one of my arms or hands over 30 days ago.

I can join the study's sessions as approved by the stroke rehab therapist.

I am 21 years old or older.

Exclusion Criteria

I have significant difficulty speaking or understanding language.

I have been found to have difficulty making informed decisions about my care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in an 8-week stroke tele-rehabilitation program, including cognitive rehabilitation and occupational therapy for arm/hand function

8 weeks

13 sessions (tele-rehabilitation)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Post-assessment within 10 days post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Rehabilitation
• Occupational Therapy

Trial Overview The study tests the addition of cognitive rehabilitation to a standard occupational therapy tele-rehabilitation program for stroke recovery. It evaluates improvements in mental function, participation in activities, arm use, and overall quality of life.

How Is the Trial Designed?

Group I: Cognitive Rehabilitation + Occupational Therapy (Telerehabilitation) Experimental Treatment 2 Interventions

A trained OT will deliver the 8-week stroke telerehabilitation program. There will be 13 total sessions with 2 sessions/week for the first 5 weeks and 1 session/week for the last 3 weeks. The cognitive rehabilitation and OT components will be titrated as follows: * Sessions 1-4 will focus on cognitive rehab. * Sessions 5-10 will review/provide additional cognitive rehab and deliver OT. * Sessions 11-13 may briefly review cognitive rehab but focus primarily on OT.

Cognitive Rehabilitation is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Cognitive Rehabilitation for:

• Stroke rehabilitation
• Cognitive impairment
• Neurological disorders

Approved in United States as Cognitive Rehabilitation for:

• Stroke rehabilitation
• Traumatic brain injury
• Neurocognitive disorders

Approved in Canada as Cognitive Rehabilitation for:

• Stroke rehabilitation
• Cognitive impairment
• Acquired brain injury

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

Published Research Related to This Trial

A systematic review of 112 studies on cognitive rehabilitation for traumatic brain injury (TBI) and stroke found strong evidence supporting interventions for attention, memory, social communication skills, and executive function, indicating effective treatment options for cognitive disabilities.

The review also highlighted the effectiveness of specific interventions for visuospatial rehabilitation after right hemisphere stroke and for addressing aphasia and apraxia after left hemisphere stroke, providing a solid foundation for evidence-based rehabilitation protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based cognitive rehabilitation: updated review of the literature from 2003 through 2008. Cicerone, KD., Langenbahn, DM., Braden, C., et al.[2022]

This paper introduces a cognitive rehabilitation model specifically designed for occupational therapy, filling a gap in the literature regarding brain function and dysfunction in adults with brain injuries.

The model emphasizes an information processing perspective for cognitive rehabilitation and compares it with three other treatment approaches, highlighting the need for clear definitions and theoretical foundations in the field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation: a model for occupational therapy. Abreu, BC., Toglia, JP.[2019]

Occupational therapy (OT) interventions show small but significant improvements in primary activities of daily living (ADL), extended ADL, and social participation for stroke patients, based on a review of 32 studies including 18 randomized controlled trials.

While comprehensive OT interventions are effective, the evidence for specific interventions like splint provision is insufficient, highlighting the need for more research to strengthen evidence-based practices in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occupational therapy for stroke patients: a systematic review. Steultjens, EM., Dekker, J., Bouter, LM., et al.[2022]

A survey of 102 Australian occupational therapists revealed that a client-centred approach is the most commonly used method for treating cognitive impairment in stroke patients, with 81.3% using it frequently for inpatients.

Despite a majority of therapists relying on their own experience and colleagues' opinions for intervention decisions, only 60.8% reported using research literature, indicating a gap in evidence-based practice in this field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of patients with cognitive impairment after stroke: a survey of Australian occupational therapists. Koh, CL., Hoffmann, T., Bennett, S., et al.[2016]

Intensive occupational therapy (AOT) significantly improved rehabilitation outcomes for patients with acute stroke, leading to better Functional Independence Measure (FIM) and National Institutes of Health Stroke Scale (NIHSS) scores, and reduced hospitalization time.

The study, which analyzed data from 3,501 stroke patients, found that AOT was particularly beneficial for those with severe limitations in daily activities and cognitive impairments, suggesting that more intensive therapy can lead to greater improvements in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of active occupational therapy in patients with acute stroke: A propensity score-weighted retrospective study. Yamakawa, S., Nagayama, H., Tomori, K., et al.[2023]

Occupational therapy (OT) shows some potential benefits for cognitive impairment (CI) after stroke, with low-certainty evidence indicating improvements in global cognitive performance and specific cognitive abilities like sustained visual attention and working memory.

Despite these findings, the overall effectiveness of OT for improving daily living activities and community integration remains unclear, with many outcomes showing low or very low certainty evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does occupational therapy improve activities of daily living and/or cognitive abilities in stroke patients with cognitive impairment? A Cochrane Review summary with commentary. Cecchi, F.[2023]

Cognitive deficits can lead to significant safety risks, including medication errors and accidents, especially in rehabilitation patients.

Integrating recommendations from various healthcare disciplines and providing education and counseling are crucial strategies to prevent adverse outcomes in patients with cognitive impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient safety considerations in the rehabilitation of the individual with cognitive impairment. Tyson, BT., Pham, MT., Brown, NT., et al.[2012]

Cognitive rehabilitation is crucial for individuals with cerebral injuries, as it helps address cognitive impairments that affect their daily lives.

The proposed Functional Model of Cognitive Rehabilitation emphasizes using real-life activities in natural settings, which can enhance the effectiveness of occupational therapy in helping clients regain their functional roles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A functional model of cognitive rehabilitation in occupational therapy. Lee, SS., Powell, NJ., Esdaile, S.[2017]

A study of 462 Swedish occupational therapists revealed that their primary practice pattern involves using activities of daily living (ADL) for both assessment and therapy, regardless of the specific cognitive impairments of clients with acquired brain injuries.

Therapies often focus on improving executive functioning abilities and emphasize a collaborative approach that includes clients, their relatives, and other staff, although the theoretical frameworks used are generally broad and not specifically tailored to cognitive functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occupational therapist practice patterns in relation to clients with cognitive impairment following acquired brain injury. Holmqvist, K., Ivarsson, AB., Holmefur, M.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10902044/

Cognitive telerehabilitation: an expert consensus paper on ... The aim of this consensus paper is to investigate the current evidence on the use and effectiveness of TR in the cognitive field.

2. research.aota.org research.aota.org/ajot/article/73/Supplement_2/7312410010p1/6616/Cognition-Cognitive-Rehabilitation-and

Cognition, Cognitive Rehabilitation, and Occupational ... A substantive body of literature supports interventions that advance occupational performance in people with cognitive impairments from stroke ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06555302

Cognitive Priming for Stroke Tele-rehabilitation The goal of this pilot study is to investigate whether adding cognitive rehabilitation to an existing occupational therapy (OT) stroke telerehabilitation ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6464961/

Occupational therapy for cognitive impairment in stroke patients There are a number of different intervention strategies that occupational therapists may use when working with people who have cognitive impairment post‐stroke.

5. mdpi.com mdpi.com/2077-0383/14/7/2197

Effectiveness of Occupational Therapy Interventions on ... Conclusions: Performance on ADLs improved significantly according to the COPM, whereas no significant improvements in cognitive or physical function were ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04472351

NCT04472351 | Cognitive Training in Stroke Rehabilitation This is a randomized, controlled pilot study to evaluate the efficacy of "ASCEND-I" (A Strategy and Computer-based intervention to ENhance Daily cognitive ...

7. aetna.com aetna.com/cpb/medical/data/200_299/0214.html

Cognitive Rehabilitation - Medical Clinical Policy Bulletins Cognitive behavior therapy (also known as cognitive therapy) is a form of psychotherapy that emphasizes the role of thought patterns in moods and behaviors.

8. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.121.034218

Rehabilitation of Cognitive Deficits Poststroke: Systematic ... This systematic review and meta-analysis evaluate the effectiveness of rehabilitation interventions across multiple domains of cognitive function.