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New treatment option for Stroke
Official title Brain Computer Interface (BCI) Integrated Wearable Hand Robotic Glove System for Upper Limb Stroke Rehabilitation
ClinicalTrials.gov ID: NCT06076928
What this study is testing
- What it's testing
- Upper extremity (UE) recovery remains a huge rehabilitation challenge with largely incomplete recovery of the upper limb post stroke. This is due to heavier priorities placed on other stroke competencies such as mobility, activities of daily living training and home integration which results in suboptimal amounts of time spent in upper limb training post stroke.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 85
You may be able to join if
- Age 21-85 years, males and females
- First diagnosis of stroke (ischemic or haemorrhagic), confirmed by neurologist/neurosurgeon/CT/MRI imaging
- \> 16 weeks post stroke
- Hemiplegic pattern of post-stroke weakness
- MRC ≥ 2/5 motor power and above for shoulder abduction \& elbow flexion
You likely can't join if
- Neurological
- Recurrent stroke
- Diagnosis of neurodegenerative disease; e.g. Parkinson's' disease, Dementia, ALS Medical: \- unstable medical or neurological conditions, life...
- 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...
See the full eligibility criteria
- Age 21-85 years, males and females
- First diagnosis of stroke (ischemic or haemorrhagic), confirmed by neurologist/neurosurgeon/CT/MRI imaging
- \> 16 weeks post stroke
- Hemiplegic pattern of post-stroke weakness
- MRC ≥ 2/5 motor power and above for shoulder abduction \& elbow flexion
- MRC 0 to 4/5 motor power and above for finger flexors \&/or extensors of thumb, index, middle fingers
- Screening Fugl-Meyer wrist hand sub score \<18/24
- Spasticity MAS \<3 for thumb, index, and middle fingers
- Able to discriminate thumb and index sensation to pain
- Hand sizes within 170-200mm (length) \&75-85mm (width), compatible with HandyRehab robotic glove
- BCI compatible brain states using a standardised screening protocol
- Able to understand simple commands with Mini Mental state examination scores MMSE \> 21/30)
- Able to give informed consent
- people who are unable to clear BCI screening 11. will be assigned by chance to either CT or HR groups.
- 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...
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Singapore, Singapore, Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore, Singapore, Singapore. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.