Health Condition 1: I63- Cerebral infarction
Conditions
Interventions
Intervention1: Robot assisted upper limb therapy at home: For the intervention group, patients and caregivers will receive an orientation to the standard ADL-based home therapy program and robot-assis
Sponsors
Christian Medical College Vellore
Eligibility
Inclusion criteria
Inclusion criteria: First-ever stroke leading to a moderate arm paresis (FMA greater than 50) Between 30 to 90 days post-stroke VFE greater than 3deg (needs to be checked) Age greater than 45 years, with classical atherosclerotic risks for stroke Sufficient cognitive abilities (MoCA score greater than 26) Living in and around the hospital (less than 100km radius); discharged from the hospital and living at home. Strokes included as per TOAST criteria: (1) Large-Artery atherosclerosis, (2) Cardio-embolism, (3) Small-vessel occlusion.
Exclusion criteria
Exclusion criteria: Recurrent stroke or patient with pre-stroke MRS greater than or equal to 1 Not having a caregiver/supervisor at home Severe post-stroke depression Severe aphasia Psychiatric disorders Other conditions like acquired brain injury contribute to arm and hand impairment. Other stroke complications, such peri arthritis, shoulder subluxation, and CRPS. Any other medical condition that makes the patient unsuitable for upper-limb therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All participants will be assessed by a blinded assessor at 3 time points: A0: Before the start of the intervention. A1: Immediately after the completion of the 4-week intervention. A2: 6-month post-stroke time point of each study participant. Fugl-Meyer Assessment (FMA) scale will be the primary outcome measure of the study. It will be assessed at all three assessment time points A0, A1, and A2.Timepoint: All participants will be assessed by a blinded assessor at 3 time points: A0: Before the start of the intervention. A1: Immediately after the completion of the 4-week intervention. A2: 6-month post-stroke time point of each study participant. Fugl-Meyer Assessment (FMA) scale will be the primary outcome measure of the study. It will be assessed at all three assessment time points A0, A1, and A2. | — |
Secondary
| Measure | Time frame |
|---|---|
| Action Research Arm Test Robotic assessment with PLUTO & MARS Arm use assessment using the wearable inertial sensors Motor Activity Log EuroQual (EQ-5D) Subjective Index of Physical & Social Outcome (SIPSO) Modified Rankin Scale Complex Regional Pain Syndrome (CRPS) Montreal Cognitive Assessment (MOCA) Patient Health Questionnaire (PHQ9) Caregiver Strain Index (CSI)Timepoint: Baseline, after the intervention (four weeks), & six months after the start of the intervention.;Adherence to therapy – based on usage data from the robots, & the training log diaries. Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) Semi-structured interview to evaluate their experience with home therapyTimepoint: At the end of the intervention (four weeks).;Clinical and technical support will be computed based on the number of times the participant called during the study, the reason for the call (Technical, Clinical), and the duration of the call Adverse Events Dropout questionnaire: If a participant withdraws from the study, the reason for dropout will be recorded.Timepoint: Assessed during the intervention | — |
Countries
India
Contacts
Public ContactSivakumar Balasubramanian
Christian Medical College Vellore
Outcome results
None listed