Sensory-Motor Rehabilitation for Stroke

Overseen By Soh-Hyun Hur, B.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Disqualifiers: Unstable conditions, Cardiovascular disorders, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 6

Duration: 3 weeks

140 Participants Needed

Trial Summary

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 Stretching and Active Movement Training, Sensorimotor Rehabilitation, Motor-Sensory Rehabilitation for stroke patients?

Research suggests that combining various sensory and motor rehabilitation techniques can improve motor function in stroke patients. While evidence for active sensory training is limited, passive sensory training has shown moderate effectiveness in enhancing limb activity and motor function. ^{1 2 3 4 5}

Is sensory-motor rehabilitation safe for humans?

The research does not specifically address safety concerns, but sensory-motor rehabilitation methods like stretching and active movement training have been studied in stroke patients without reported safety issues. ^{1 2 3 6 7}

How is the Stretching and Active Movement Training treatment for stroke different from other treatments?

Stretching and Active Movement Training is unique because it combines both sensory and motor rehabilitation, focusing on retraining sensory function, which is often overlooked in stroke recovery. This approach aims to improve both sensation and motor function, potentially enhancing overall recovery compared to treatments that focus solely on motor rehabilitation. ^{1 2 3 8 9}

What is the purpose of this trial?

Early after stroke, patients often have significant motor impairment and sensory deficit. Evidence has demonstrated heightened plasticity and significant recovery in the acute phase (first months) post stroke but there has been a lack of effective and practical protocols and devices for early intensive sensorimotor therapy.This research study will conduct a randomized clinical trial of an intensive motor-sensory rehabilitation on patients with acute stroke using a wearable rehabilitation robot. The primary aims are to facilitate sensorimotor recovery, reduce ankle impairments, and improve balance and gait functions. This clinical trial will be conducted on the Study and Control groups of acute stroke survivors.

Research Team

Li-Qun Zhang, Ph.D.

Principal Investigator

University of Maryland, Baltimore

Eligibility Criteria

This trial is for stroke survivors aged 18-80 with ankle impairments and hemiplegia or hemiparesis. It's suitable for those who've had their first unilateral acute stroke, either hemorrhagic or ischemic, from 24 hours to a year post-stroke. Excluded are individuals with mild/no impairment, severe cardiovascular issues, cognitive impairments preventing instruction following, unstable medical conditions, leg ulcers/wounds below the knee, or severe leg pain.

Inclusion Criteria

I have issues with my ankle.

I have weakness or paralysis on one side of my body.

I had my first stroke, either bleeding or clot-based, between 24 hours and 1 year ago.

Exclusion Criteria

You have a medical condition that makes it hard for you to train and exercise regularly.

I experience severe leg pain.

I have an open wound or recent surgery below the knee of the limb being treated.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive intensive motor-sensory rehabilitation using a wearable rehabilitation robot for 3 weeks

3 weeks

5 sessions per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Stretching and Active Movement Training

Trial Overview The study tests an intensive motor-sensory rehabilitation using a wearable robot on patients after a stroke. The goal is to aid sensorimotor recovery and improve balance and walking by reducing ankle impairments. Participants will be randomly assigned to either the Study group receiving therapy or Control group.

Participant Groups

Group I: Study group Experimental Treatment 1 Intervention

Subjects in the Study group will receive stretching and active movement training with robotic guidance and intelligent control

Group II: Control group Experimental Treatment 1 Intervention

Subjects in the Control group will receive stretching and active movement training without robotic guidance.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Northwestern Memorial Hospital

Collaborator

Trials

42

Recruited

15,800+

Findings from Research

Passive sensory training shows moderate effectiveness in improving upper and lower limb activity measures in stroke patients, based on a meta-analysis of 38 trials involving 1,093 participants.

Evidence for active sensory training is limited but suggests potential benefits for sensorimotor function, indicating a need for further high-quality research to better understand its effectiveness in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Sensory Retraining Improve Sensation and Sensorimotor Function Following Stroke: A Systematic Review and Meta-Analysis. Serrada, I., Hordacre, B., Hillier, SL.[2020]

Passive sensory training after stroke shows moderate effectiveness in improving sensory impairment and hand function, based on a meta-analysis of three studies.

Active sensory training lacks sufficient empirical evidence to support its effectiveness, highlighting the need for more high-quality research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence for the retraining of sensation after stroke: a systematic review. Schabrun, SM., Hillier, S.[2022]

A systematic review of 8 studies on active sensory interventions for post-stroke upper limb recovery found that techniques like mirror therapy and motor imagery show promise, but strong evidence for their effectiveness in improving motor recovery is lacking.

The review highlights the need for a comprehensive active sensory protocol that combines cognitive, sensory, motor, and functional elements, and calls for high-quality randomized trials to better evaluate these therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active Sensory Therapies Enhancing Upper Limb Recovery Among Poststroke Subjects: A Systematic Review. Arya, KN., Pandian, S., Joshi, AK., et al.[2022]

Conventional rehabilitation strategies for stroke patients, such as Bobath and motor relearning, remain the primary methods used in clinical practice, but there is a growing incorporation of advanced techniques like robotics and virtual reality to enhance recovery.

The proposal of an integrated training package that combines various rehabilitation methods tailored to the patient's recovery phase could lead to significant functional improvements for stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progress in sensorimotor rehabilitative physical therapy programs for stroke patients. Chen, JC., Shaw, FZ.[2022]

In a study involving 20 chronic stroke patients, a three-week gait-oriented physiotherapy program provided a total of 19 hours of instructed therapy and 28 hours of self-initiated training, emphasizing the importance of active practice in rehabilitation.

The combination of various training methods, including electromechanical gait trainers and self-initiated exercises, led to significant improvements in gait ability, highlighting the effectiveness of structured and diverse rehabilitation approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How much exercise does the enhanced gait-oriented physiotherapy provide for chronic stroke patients? Peurala, SH., Pitkänen, K., Sivenius, J., et al.[2016]

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]

In a study involving 45 stroke patients, a combination of joint mobilization and active stretching significantly improved both ankle joint range of motion and gait parameters (cadence, speed, stride length) after 6 weeks of therapy.

While joint mobilization alone increased ankle range of motion, it did not affect gait variables, highlighting the importance of combining therapies for comprehensive rehabilitation in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of joint mobilization and stretching on the range of motion for ankle joint and spatiotemporal gait variables in stroke patients. Cho, KH., Park, SJ.[2020]

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]

In a study involving 167 adults with chronic stroke, all four upper limb motor rehabilitation programs led to similar improvements in tactile sensation, indicating that various rehabilitation methods can effectively enhance sensory recovery post-stroke.

Approximately one-third of participants experienced significant improvements in their tactile sensitivity, with those having poorer baseline sensation showing the greatest gains, suggesting that motor rehabilitation can be a valuable motivator for recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tactile Sensation Improves Following Motor Rehabilitation for Chronic Stroke: The VIGoROUS Randomized Controlled Trial. Borstad, A., Nichols-Larsen, D., Uswatte, G., et al.[2022]

References

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

Does Sensory Retraining Improve Sensation and Sensorimotor Function Following Stroke: A Systematic Review and Meta-Analysis. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Evidence for the retraining of sensation after stroke: a systematic review. [2022]

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

Active Sensory Therapies Enhancing Upper Limb Recovery Among Poststroke Subjects: A Systematic Review. [2022]

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

Progress in sensorimotor rehabilitative physical therapy programs for stroke patients. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

How much exercise does the enhanced gait-oriented physiotherapy provide for chronic stroke patients? [2016]

6. 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]

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

Effects of joint mobilization and stretching on the range of motion for ankle joint and spatiotemporal gait variables in stroke patients. [2020]

8. 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]

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

Tactile Sensation Improves Following Motor Rehabilitation for Chronic Stroke: The VIGoROUS Randomized Controlled Trial. [2022]