Clinical outcome analysis of patients with contralateral C7 nerve transfer for spastic upper arm paralysis

Not Applicable

Conditions: Health Condition 1: G811- Spastic hemiplegia

Registration Number: CTRI/2019/06/019843

Lead Sponsor: SBKS MIRC Sumandeep Vidyapeeth

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1 Spastic hemiplegia following different causes of central neurologic injury, such as stroke, traumatic brain injury, and cerebral palsy, principally presenting as difficulty in hand opening;

2. Normal mental and linguistic functions;

3. No restrictions as to age or gender;

4. Had received regular rehabilitation therapy for at least 2 years and ceased

improving in the paralyzed hand;

5. Willing (or their parents were willing if the patients were underage) to receive surgeries to achieve further functional improvement;

6. Central neurologic injury only involving the hemisphere contralateral to the

paralyzed hand, as indicated by brain MRI scans.

Exclusion Criteria

1. Presence of co-morbid medical conditions contraindicating surgery.

2. Personal or relativesâ?? decision to refuse surgery;

3. Psychological or mental abnormalities;

4. Presence of severe, fixed contracture or joint deformity;

5. Mental retardation or poor learning and communicating capacity (relative

contraindication).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Incidence and intensity of reduction in spasticity. <br/ ><br>Outcome measure: MAS and FMA Score at 2 months interval <br/ ><br>2. Incidence and level of improvement in tone of paralyzed muscles. <br/ ><br>Outcome measure: Muscle Charting (MRC grading) and EMG at 4 months <br/ ><br>intervalTimepoint: Every 2 months up to 2 years

Secondary Outcome Measures

Name	Time	Method
1. Improvement in RoM (Range of Motion) <br/ ><br>Outcome Measure: Goniometry <br/ ><br>2. Assessment of improvement in sensorimotor functions <br/ ><br>Outcome Measure: 2 point discrimination, grip strength, pinch <br/ ><br>3. Improvement in QoL â?? as measured by ease of doing activities like dressing/buttoning, self-feeding, combing hair, bathing, operating mobile phone etc. <br/ ><br>Outcome Measure: patient reported outcome <br/ ><br>4. To evaluate cost effectiveness of the procedure.Timepoint: Every 2 months up to 2 years