Health Condition 1: G968- Other specified disorders of central nervous system
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Stroke occurred within six months 2. 1st episode of stroke 3. Age between 35 to 75 years, hemodynamically stable. 4. Mild or no cognitive Deficit (Mini Mental Status Examination (MMSE) score more than 21 points)) 5. Presence of minimal voluntary active shoulder (abduction and flexion) and elbow (flexion) (at least 10-20 degree active ROM at shoulder abduction and flexion and elbow movements (10-20 degree active flexion) 6. Presence of spasticity in the elbow flexors of grade one plus (1+) or more in Modified Ashworth scale (MAS)
Exclusion criteria
Exclusion criteria: 1. Recurrent strokes 2. Presence of neuropathic pain in the affected upper limb 3. Presence of contractures of the affected wrist and fingers 4. Severe spasticity of the affected limb (MAS more than 3) 5. Cognitive dysfunction (Mini Mental Status Examination (MMSE) score less than 21 points) 6. Hemodynamically unstable patients 7. Presence of previous neurological disorder (due to any etiology)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Motor recovery: Motor recovery will be assessed with Fugl-Meyer Assessment scale for upper extremity (FMA-UE). The FMA-UE is a widely used scale to assess UE motor impairment. The maximum possible score on the FMA-UE is 66, with higher scores indicating better motor function.Timepoint: Assessments will be done at the baseline visit (V0); then at follow-up visits V1, V2, and V3. (V1; 6-7 weeks follow-up; V2: 3 months follow-up; V3: 6 months follow-up). | — |
Secondary
| Measure | Time frame |
|---|---|
| The Upper Limb function will be assessed with hand-function (HF) domain score of Stroke Impact Scale (SIS) and The Wolf Motor Function Test (WMFT).Timepoint: Assessments will be done at the baseline visit (V0); then at follow-up visits V1, V2, and V3. (V1; 6-7 weeks follow-up; V2: 3 months follow-up; V3: 6 months follow-up).;Quality of life (QoL) will be assessed with SIS scale.Timepoint: Assessments will be done at the baseline visit (V0); then at follow-up visits V1, V2, and V3. (V1; 6-7 weeks follow-up; V2: 3 months follow-up; V3: 6 months follow-up).;Spasticity of Upper Limb will be assessed with modified Ashworth Scale (MAS) at elbow and wrist.Timepoint: Assessments will be done at the baseline visit (V0); then at follow-up visits V1, V2, and V3. (V1; 6-7 weeks follow-up; V2: 3 months follow-up; V3: 6 months follow-up). | — |
Countries
India
Contacts
All India Institute of Medical Sciences, Bhubaneswar