Upper limb hemiparesis due to stroke Nervous System Diseases Hemiparesis
Conditions
Interventions
Participants are allocated to either test or control study group using stratification (a dynamic minimization protocol), balancing impairment (2 levels: upper-limb Fugl-Meyer scoreless or more than 25
Sponsors
Medical Research Council
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or over 2. Cortical or capsular stroke >6 months before participation and no evidence for another stroke in the last 6 month 3. FMA-UE score within 5 and 50 points, with no more than 5-point difference on repeat testing at two weeks interval 4. Preserved vision across the visual field, allowing detection of all the stimuli displayed during the robot-assisted motor tasks 5. Ability to maintain balance when seated 6. Preserved basic cognitive function including understanding instruction as assessed by Mini Mental State Examination 7. Available during the full period of the study
Exclusion criteria
Exclusion criteria: 1. Prolonged pain in the affected upper limb or during movement assessed using the Likert Pain Scale or injury in the hemiparetic hand/arm 2. Severe spasticity involving elbow/shoulder movements =3 in Modified Ashworth Scale for any tested elbow/shoulder posture 3. Receiving physiotherapy during the study period 4. Cerebellar lesion assessed by MRI or by clinical report as provided by the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Upper limb movement is measured by an experienced physiotherapist using the upper-limb Fugl-Meyer (UL-FM) scale (max score: 66), twice before the intervention in two week gap (baseline), few days after the last intervention session (post-training) and 4-weeks later (follow-up). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Muscle power is measured using the MRC Muscle Power scale 2. Spasticity is measured using the Modified Ashworth Scale 3. Everyday motor function is measured using the Motor Assessment Scale 4.Functional independence and performance in activities of daily living is measured using the Barthel index All of the above are assessed by an experienced clinician (physiotherapist) twice before the intervention in two week gap (baseline), few days after the last intervention session (post-training) and 4-weeks later (follow-up) 5. Levels of robot guidance and assistance were measured using the robot's sensors. These data are recorded automatically throughout all the robot-mediated movement sessions and stored in files on a computer. For outcome, we use the average assistance and guidance forces per movement condition in the following robot-mediated performance assessment sessions: pre-intervention (baseline), few days after the last intervention session (post-training) and 4-weeks later (follow-up) | — |
Countries
United Kingdom
Outcome results
None listed