Cognitive-Somatosensory-Motor Training for Stroke

(iCOSMO Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Mark Bayley, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University Health Network, Toronto

Disqualifiers: CNS dysfunction, Non-stroke pathology, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The iCOSMO study investigates the feasibility and beneficial effects of an intervention combining sensation, motor and cognition to improve arm and hand function after chronic stroke.

Do I have to stop taking my current medications for the trial?

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

What data supports the idea that Cognitive-Somatosensory-Motor Training for Stroke is an effective treatment?

The available research shows that Cognitive-Somatosensory-Motor Training can improve motor function in stroke patients. For example, one study found that somatosensory stimulation, which is part of this training, led to better hand motor function in patients with chronic strokes. This improvement was greater than in sessions without this stimulation, and the benefits lasted for at least 30 days. This suggests that the treatment can be a helpful tool in stroke rehabilitation, especially for those with certain types of brain injuries. ^{1 2 3 4 5}

What safety data exists for Cognitive-Somatosensory-Motor Training for stroke?

The provided research does not directly address safety data for Cognitive-Somatosensory-Motor Training or its variants like iCOSMO. The studies focus on the effectiveness of somatosensory retraining and stimulation in improving motor function after stroke, but they do not specifically mention safety outcomes or adverse effects related to these interventions. ^{1 3 4 6 7}

Is the treatment Cognitive-Somatosensory-Motor Training for Stroke promising?

Yes, Cognitive-Somatosensory-Motor Training for Stroke is promising because it combines physical and sensory training to improve motor and sensory functions in stroke patients. Studies show that somatosensory stimulation can enhance motor function and help maintain training benefits, making it a valuable tool for stroke rehabilitation. ^{2 3 4 6 8}

Research Team

Mark Bayley, MD

Principal Investigator

Toronto Rehabilitation Institute

Eligibility Criteria

The iCOSMO trial is for individuals who have had a stroke and are looking to improve the function of their arm and hand. Specific eligibility criteria details were not provided.

Inclusion Criteria

I have weakness or sensory loss in my arms.

I have been diagnosed with a stroke.

It has been over 6 months since my stroke.

Exclusion Criteria

I have had a brain disorder other than a stroke.

I have arm or hand issues not caused by a stroke.

I can follow instructions and provide consent for treatment.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants are tested at the start and end of the baseline phase

1 week

Treatment

Participants receive the iCOSMO intervention or a home-based exercise programme for 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• integrated Somatosensory-MOtor training using a COgnitive approach(iCOSMO) (Behavioural Intervention)

Trial Overview This study tests two types of training programs: GRASP, which patients do at home, and iCOSMO, which integrates sensory, motor, and cognitive exercises to aid recovery after a chronic stroke.

Participant Groups

Group I: iCOSMO Experimental Treatment 1 Intervention

20 participants will receive the iCOSMO intervention. iCOSMO consists of two training approaches that will include active touch and movement exploratory procedures during goal-oriented tasks as well as robotic training using the Kinarm Exoskeleton device.

Group II: Home GRASP Active Control 1 Intervention

20 participants will receive the control intervention. The control group will receive a matched dose of a home-based exercise programme. The home-based exercise programme will be based on the Home Graded Repetitive Arm Supplementary Program.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Dr. Brad Wouters

University Health Network, Toronto

Chief Medical Officer since 2020

MD from University of Toronto

Dr. Kevin Smith

University Health Network, Toronto

Chief Executive Officer since 2018

Professor at McMaster University and University of Toronto

StrokeCog clinical training platform

Collaborator

Trials

1

Recruited

40+

Findings from Research

Cognitive sensory motor training therapy showed promising results in improving upper extremity motor function in seven patients with chronic stroke or traumatic brain injuries, with an average increase of 7.7 points in Action Research Arm (ARA) scores over 2.5 months of training.

All patients demonstrated improvement, suggesting that this therapy could be a valuable rehabilitation method, although further studies with larger sample sizes are needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved function of hemiplegic upper extremity after cognitive sensory motor training therapy in chronic stroke patients: preliminary report of a case series. Wongphaet, P., Butrach, W., Sangkrai, S., et al.[2007]

The COMPoSE intervention is a novel rehabilitation program designed for stroke patients that integrates both somatosensory and motor training to address upper limb deficits, utilizing a standardized training matrix over 10 sessions in 3 weeks.

This approach includes specific training variables like grasp pressure and object texture, along with feedback mechanisms and high-dose repetitive practice, aiming to enhance skill acquisition and improve functional outcomes in stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COMbined Physical and somatoSEnsory training after stroke: Development and description of a novel intervention to improve upper limb function. Gopaul, U., van Vliet, P., Callister, R., et al.[2019]

Somatosensory retraining programs can significantly improve somatosensory discrimination skills in the arm of stroke survivors, with an average effect size of 0.85 across various modalities, indicating a meaningful impact on sensory recovery.

There is a trend suggesting that these retraining programs may also enhance motor function and arm use, as indicated by narrative analysis of studies involving 89 participants, although more research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of somatosensory retraining for improving sensory function in the arm following stroke: a systematic review. Turville, ML., Cahill, LS., Matyas, TA., et al.[2022]

In a study involving 11 stroke patients with cortical involvement, median nerve stimulation (MNS) significantly improved hand motor function compared to control stimulation, indicating its efficacy as a rehabilitation tool.

Patients who received MNS not only showed immediate improvements but also maintained these benefits 30 days later, suggesting that somatosensory stimulation can help consolidate motor training effects in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of somatosensory stimulation on motor function in chronic cortico-subcortical strokes. Conforto, AB., Cohen, LG., dos Santos, RL., et al.[2018]

A randomized clinical trial involving 40 ambulant stroke patients showed that combining motor imagery (MI) training with physical practice significantly improved lower extremity muscle strength and gait performance compared to physical practice alone.

The experimental group that received MI training demonstrated greater improvements in hip, knee, and ankle muscle strength, as well as faster gait speed, indicating that MI can enhance rehabilitation outcomes in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor Imagery Training on Muscle Strength and Gait Performance in Ambulant Stroke Subjects-A Randomized Clinical Trial. Kumar, VK., Chakrapani, M., Kedambadi, R.[2020]

In a study of 55 adults with moderate-to-severe upper limb hemiparesis, active somatosensory stimulation combined with motor training significantly improved motor function outcomes compared to sham stimulation, as measured by the Wolf Motor Function Test and Action Research Arm Test.

While the active stimulation showed benefits in motor function, it did not significantly affect the Fugl-Meyer Assessment, and the clinical relevance of the observed differences remains to be determined, suggesting further research is needed to explore its impact on overall disability and recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nerve Stimulation Enhances Task-Oriented Training for Moderate-to-Severe Hemiparesis 3-12 Months After Stroke: A Randomized Trial. Carrico, C., Westgate, PM., Salmon Powell, E., et al.[2019]

Recent research highlights the importance of combining training with various interventions, such as somatosensory input and cortical stimulation, to improve motor recovery in stroke patients.

Studies show that these strategies can enhance cortical plasticity, suggesting new ways to optimize rehabilitation efforts and improve outcomes for individuals with stroke-related disabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translational studies in neurorehabilitation: from bench to bedside. Floel, A., Cohen, LG.[2019]

The scoping review analyzed 117 articles from 2005 to 2015 to understand how adults and older adults process somatosensory information and the interventions available for regaining function after a stroke.

There is a significant gap in knowledge regarding the impact of somatosensory function on daily activities, highlighting the need for a multidisciplinary approach that focuses on performance and participation outcomes in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The State-of-the-Science on Somatosensory Function and Its Impact on Daily Life in Adults and Older Adults, and Following Stroke: A Scoping Review. Carey, LM., Lamp, G., Turville, M.[2017]

References

1. Thailand pubmed.ncbi.nlm.nih.gov

Improved function of hemiplegic upper extremity after cognitive sensory motor training therapy in chronic stroke patients: preliminary report of a case series. [2007]

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

COMbined Physical and somatoSEnsory training after stroke: Development and description of a novel intervention to improve upper limb function. [2019]

3. England pubmed.ncbi.nlm.nih.gov

The effectiveness of somatosensory retraining for improving sensory function in the arm following stroke: a systematic review. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Effects of somatosensory stimulation on motor function in chronic cortico-subcortical strokes. [2018]

5. India pubmed.ncbi.nlm.nih.gov

Motor Imagery Training on Muscle Strength and Gait Performance in Ambulant Stroke Subjects-A Randomized Clinical Trial. [2020]

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

Nerve Stimulation Enhances Task-Oriented Training for Moderate-to-Severe Hemiparesis 3-12 Months After Stroke: A Randomized Trial. [2019]

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

Translational studies in neurorehabilitation: from bench to bedside. [2019]

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

The State-of-the-Science on Somatosensory Function and Its Impact on Daily Life in Adults and Older Adults, and Following Stroke: A Scoping Review. [2017]