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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this pilot study is to investigate whether adding cognitive rehabilitation to an existing occupational therapy (OT) stroke telerehabilitation program will improve stroke survivors' functioning. The main question it aims to answer is whether this intervention improves cognition, participation, upper extremity use in real-world activities, and mood/quality of life. Participants will be asked to engage in an 8-week stroke tele-rehabilitation program (13 sessions), which includes both cognitive rehabilitation and OT for arm/hand function, and complete assessments before and after the intervention.

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 data supports the effectiveness of the treatment Cognitive Rehabilitation + Occupational Therapy for Stroke?

Research shows that occupational therapy (OT) is important for stroke rehabilitation, and cognitive rehabilitation helps people with brain injuries manage cognitive challenges. Combining these therapies can help stroke patients improve their daily functioning and regain independence. ^{1 2 3 4 5}

Is cognitive rehabilitation and occupational therapy safe for humans?

Cognitive rehabilitation and occupational therapy are generally considered safe for humans, especially when healthcare professionals provide education and prevention counseling to limit adverse safety outcomes in patients with cognitive impairments. ^{2 4 6 7 8}

How is the treatment of Cognitive Rehabilitation + Occupational Therapy for stroke different from other treatments?

This treatment is unique because it combines cognitive rehabilitation with occupational therapy to help stroke patients improve their daily functioning by using activities in real-life settings. It focuses on minimizing cognitive deficits and enabling patients to fulfill their roles in everyday life, which is different from other treatments that may not emphasize practical, functional activities. ^{2 4 5 7 9}

Eligibility Criteria

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

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of active occupational therapy in patients with acute stroke: A propensity score-weighted retrospective study. [2023]

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

A functional model of cognitive rehabilitation in occupational therapy. [2017]

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

Occupational therapy for stroke patients: a systematic review. [2022]

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

Cognitive rehabilitation: a model for occupational therapy. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Occupational therapist practice patterns in relation to clients with cognitive impairment following acquired brain injury. [2015]

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

Patient safety considerations in the rehabilitation of the individual with cognitive impairment. [2012]

7. Netherlands 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. [2023]

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

Evidence-based cognitive rehabilitation: updated review of the literature from 2003 through 2008. [2022]

9. Australia pubmed.ncbi.nlm.nih.gov

Management of patients with cognitive impairment after stroke: a survey of Australian occupational therapists. [2016]