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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to aid stroke recovery using a special wearable robot. The focus is on enhancing movement and sensation, particularly around the ankle, to improve balance and walking. Participants will receive Stretching and Active Movement Training (also known as Sensorimotor Rehabilitation) either with or without the robot's assistance. This trial suits individuals who have experienced their first stroke, have difficulty moving one side of their body, and have ankle issues. As an unphased trial, it provides 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 wearable rehabilitation robot is safe for sensorimotor rehabilitation in stroke patients?

Research has shown that stretching and active movement exercises, whether performed with a robot or not, are generally safe for individuals recovering from a stroke. Studies have found that personalized rehabilitation programs like these can enhance balance, walking, and muscle strength in stroke patients.

While specific data on side effects for this exact method is limited, robots in therapy have been well-received in similar rehabilitation settings, suggesting a low risk of harm. Prospective participants should discuss any concerns with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the sensory-motor rehabilitation techniques under study because they incorporate robotic guidance and intelligent control, which is a fresh approach to stroke recovery. Unlike traditional rehabilitation options that rely solely on manual therapy and exercise, this method uses robotics to provide precise assistance and feedback during movement training. This innovation aims to enhance the effectiveness of therapy by promoting more accurate and consistent movement patterns, potentially speeding up recovery and improving outcomes for stroke survivors.

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

This trial will compare two approaches to stretching and active movement training for stroke rehabilitation. Research has shown that robots assisting with stretching and movement exercises can enhance recovery after a stroke. Participants in the study group will receive stretching and active movement training with robotic guidance and intelligent control. Studies have found that personalized rehabilitation programs can improve balance, walking, and muscle strength. Evidence from a review of multiple studies also supports that passive sensory training can enhance limb movement in stroke patients. Additionally, using robots in physical therapy has been linked to better body movement and muscle control. Overall, these findings suggest that a wearable rehabilitation robot may improve recovery of movement and sensation in stroke survivors. ^{1 2 3 5 6}

Who Is on the Research Team?

Li-Qun Zhang, Ph.D.

Principal Investigator

University of Maryland, Baltimore

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02369770

NCT02369770 | Sensory-Motor Rehabilitation Post Stroke Hypothesis 1: Robot-guided motor relearning, stretching and active movement training (Study group) will improve the biomechanical and neuromuscular outcome ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10216461/

A Comprehensive Review of Physical Therapy Interventions ... The study found that VR training was equally as effective as CT in improving upper extremity function during the subacute phase after a stroke.

3. obrienphysicaltherapy.net obrienphysicaltherapy.net/blog/post-stroke-rehabilitation-outcomes-statistics-on-physical-therapy-effectiveness

Post-Stroke Rehabilitation Outcomes: Statistics on Physical ... Evidence consistently shows that tailored rehabilitation programs can enhance functional outcomes such as balance, gait, and muscle strength.

4. withpower.com withpower.com/trial/sensory-motor-rehabilitation-for-stroke-9c625

Sensory-Motor Rehabilitation for Stroke Passive sensory training shows moderate effectiveness in improving upper and lower limb activity measures in stroke patients, based on a meta-analysis of 38 ...

5. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2019.00402/full

Does Sensory Retraining Improve Sensation and ... Does sensory retraining improve sensation and sensorimotor function following stroke: a systematic review and meta-analysis.

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

Rehabilitation of Motor Function after Stroke - PubMed Central Rehabilitation training is the most effective way to reduce motor impairments in stroke patients. This multiple systematic review focuses both ...