Wearable robotic glove system for stroke rehabilitation

Brain Computer Interface (BCI) Integrated Wearable Hand Robotic Glove System for Upper Limb Stroke Rehabilitation: A 3-arm Randomized Controlled Trial

This study is testing a new robotic glove to see if it helps stroke patients recover their hand movement better than regular therapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 21 Years to 85 Years
• Sex: All
• Sponsor: Tan Tock Seng Hospital (Academic / other)
• Locations: 1 site (Singapore, Singapore)
• Trial ID: NCT06076928 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of a brain-computer interface integrated wearable hand robotic glove, called HandyRehab, for upper limb rehabilitation in stroke patients. The aim is to compare the usability and clinical efficacy of this novel system against conventional occupational therapy. Participants will undergo intensive training using the HandyRehab system, which is designed to facilitate neuroplasticity and improve motor functions. The study will assess feasibility, safety, and objective measures of recovery across different treatment platforms.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21-85 who have experienced their first stroke and have specific motor power and sensory criteria.

Not a fit: Patients with severe cognitive impairments or those who do not meet the BCI compatibility screening may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance upper limb recovery in stroke patients, leading to improved functional independence.

How similar studies have performed: Previous studies have shown promising results with robotic-assisted therapies in stroke rehabilitation, indicating potential for success with this novel approach.

Eligibility criteria

Inclusion Criteria:

1. Age 21-85 years, males and females
2. First diagnosis of stroke (ischemic or haemorrhagic), confirmed by neurologist/neurosurgeon/CT/MRI imaging
3. \> 16 weeks post stroke
4. Hemiplegic pattern of post-stroke weakness
5. MRC ≥ 2/5 motor power and above for shoulder abduction \& elbow flexion
6. MRC 0 to 4/5 motor power and above for finger flexors \&/or extensors of thumb, index, middle fingers
7. Screening Fugl-Meyer wrist hand sub score \<18/24
8. Spasticity MAS \<3 for thumb, index, and middle fingers
9. Able to discriminate thumb and index sensation to pain
10. Hand sizes within 170-200mm (length) \&75-85mm (width), compatible with HandyRehab robotic glove
11. BCI compatible brain states using a standardised screening protocol
12. Able to understand simple commands with Mini Mental state examination scores MMSE \> 21/30)
13. Able to give informed consent

    * Subjects who are unable to clear BCI screening 11. will be randomised to either CT or HR groups.

Exclusion Criteria:

Neurological

* Recurrent stroke
* Diagnosis of neurodegenerative disease; e.g. Parkinson's' disease, Dementia, ALS

Medical:

\- unstable medical or neurological conditions, life expectancy \<6 months, end-organ renal failure on dialysis, severe heart failure, postural hypotension, history of uncontrolled sepsis, epilepsy with seizure within 3 months of informed consent, skin conditions which could potentially be worsened by wearable robot (ulcers, open wounds, eczema, infections etc)

Postural:

* Unable to tolerate upright posture or sit unaided for \< 90min with rest breaks
* Cognitive/behavioural/visual:
* Severe dysphasia/aphasia, severe visual neglect/blindness, untreated severe depression, psychiatric illness, unable to understand study requirements

Upper limb:

* Moderate to severe spasticity (Modified Ashworth scale MAS ≥2)
* Hand/arm related pain (VAS Pain ≥ 5/10),
* Presence of finger contractures, reduced functional range of motion, limiting functional wrist/finger movements, active fractures or arthritis with deformities
* Severe limb ataxia/apraxia
* Severe post stroke hemi-anaesthesia in affected UE

BCI incompatibility:

* Motor imagery EEG signals unable to be detected
* Presence of craniectomy skull defect (affecting BCI cap fit and electrode contact)
* Concomitant participation in other interventional research trials
* Resident of nursing home or overseas country which may compromise attendance at research site
* Pregnant or lactating females will not be allowed to participate

Where this trial is running

Singapore, Singapore

• Tan Tock Seng Hospital — Singapore, Singapore, Singapore (Recruiting)

Study contacts

• Principal investigator: Karen Chua — Tan Tock Seng Hospital
• Study coordinator: Low Ai Mei Jaclyn

Conditions Stroke; Brain Computer Interface; Hand exoskeleton robot