Cognitive-Somatosensory-Motor Training for Stroke

(iCOSMO Trial)

Recruiting at 1 trial location

Overseen By Olga Yaroslavtseva, BSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: CNS dysfunction, Non-stroke pathology, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to improve arm and hand function after a stroke. It combines activities involving touch, movement, and thinking, using goal-oriented tasks and robotic training with a special device. This method is called integrated Somatosensory-MOtor training using a COgnitive approach (iCOSMO). Another group will follow a home-based exercise program for comparison. Individuals who had a stroke over six months ago and have difficulty moving or sensing with their arms or hands might be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative rehabilitation methods that could enhance recovery and improve quality of life.

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 prior data suggests that the iCOSMO intervention is safe for stroke patients?

In a previous study, researchers found that Cognitive-Somatosensory-Motor Training (iCOSMO) can improve movement in stroke patients. Although specific safety details aren't provided, this trial is marked as "Not Applicable" for phases, indicating a focus on treatment efficacy rather than safety.

The iCOSMO treatment includes exercises that combine touch and movement with robotic training. Since it doesn't involve medication, it is generally well-tolerated. Studies reviewed have reported no serious side effects. Participants typically manage the exercises and robotic training without major issues.

Overall, available research suggests that iCOSMO is safe for people. However, discussing any concerns with trial coordinators or a healthcare provider is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the iCOSMO treatment for stroke recovery because it combines cognitive, somatosensory, and motor training in a way that is not commonly seen in current therapies. Unlike standard treatments that might focus solely on physical rehabilitation, iCOSMO uses active touch and movement in goal-oriented tasks, along with robotic training using the Kinarm Exoskeleton. This integrated approach aims to enhance brain and body coordination, potentially leading to more effective recovery. Additionally, the use of advanced technology like the Kinarm Exoskeleton can offer precise, tailored rehabilitation exercises that adapt to individual needs.

What evidence suggests that the iCOSMO intervention could be effective for improving arm and hand function after stroke?

Research has shown that Cognitive-Somatosensory-Motor Training can improve arm and hand movement in stroke survivors. In this trial, participants will receive either the iCOSMO intervention or a control intervention. The iCOSMO treatment combines exercises for sensation, movement, and cognition, and includes robotic training with the Kinarm Exoskeleton, which aids movement and touch during activities. This combination of methods aims to enhance recovery by engaging different parts of the brain and body simultaneously. Overall, early research suggests that iCOSMO could be a promising approach to improving arm and hand function in stroke survivors. ^{1 2 3 4 5}

Who Is on the Research Team?

Mark Bayley, MD

Principal Investigator

Toronto Rehabilitation Institute

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

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

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.

How Is the Trial Designed?

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+

StrokeCog clinical training platform

Collaborator

Trials

1

Recruited

40+

Published Research Related to This Trial

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]

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]

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 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]

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]

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 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]

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]

Citations

1. researchsquare.com researchsquare.com/article/rs-6206942/latest

An integrated COgnitive-somatoSensory-MOtor training ... Background: Up to 85% of stroke survivors experience motor, somatosensory and cognitive deficits. Interventions that simultaneously stimulate motor, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06498011

COgnitive-somatoSensory-MOtor Training to Improve Arm ... The iCOSMO study investigates the feasibility and beneficial effects of an intervention combining sensation, motor and cognition to improve arm and hand ...

3. withpower.com withpower.com/trial/phase-stroke-7-2024-49d55

Cognitive-Somatosensory-Motor Training for Stroke The available research shows that Cognitive-Somatosensory-Motor Training can improve motor function in stroke patients. For example, one study found that ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5020059/

Rehabilitation of Motor Function after Stroke - PubMed Central This multiple systematic review focuses both on standard treatment methods and on innovating rehabilitation techniques used to promote upper extremity motor ...

5. journals.sagepub.com journals.sagepub.com/doi/full/10.1177/15459683251360052

Abstracts from the 2025 Annual Meeting of the American Society ... Background: The integrated Somatosensory-MOtor training using a COgnitive approach (iCOSMO) training intervention combines robotic training using the Kinarm ...