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

Clinical outcome analysis of patients with contralateral C7 nerve transfer with spastic upper arm paralysis: Single center, open label, prospective interventional study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/06/019843
Enrollment
20
Registered
2019-06-25
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G811- Spastic hemiplegia

Interventions

Intervention1: Surgical: Transfer of contrlateral c7 to affected side c7 Control Intervention1: Not applicable: Not applicable

Sponsors

SBKS MIRC Sumandeep Vidyapeeth
Lead Sponsor

Eligibility

Inclusion criteria

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

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).

Design outcomes

Primary

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

Secondary

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

Countries

India

Contacts

Public ContactDr Piyush Doshi

SBKS MIRC Sumandeep Vidyapeeth

dr.p.doshi@gmail.com9825226234

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026