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Surgery for relieving tightness and improving functions after brain stroke or injury

Phase 3
Conditions
Health Condition 1: O- Medical and SurgicalHealth Condition 2: G811- Spastic hemiplegia
Registration Number
CTRI/2023/11/060191
Lead Sponsor
Indian Council of Medical Research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Post-ischemic stroke patients who have spasticity (grade 3-4 of modified Ashworth scoring) even with maximal tolerated oral Baclofen and residual weakness six months after the event.

2.Post-hypertensive or tumor bleed stroke patients who have spasticity (grade 3-4 of modified Ashworth scoring) even with maximal tolerated oral Baclofen and residual weakness six months after the event.

3.Post-traumatic stroke patients who have spasticity (grade 3-4 of modified Ashworth scoring) even with maximal tolerated oral Baclofen and residual weakness six months after the event.

4.Post-surgical stroke patients who have spasticity (grade 3-4 of modified Ashworth scoring) even with maximal tolerated oral Baclofen and residual weakness six months after the event.

Exclusion Criteria

1.Medically unfit patients

2.Patients with ages less than 5 years and more than 80 years

3.Patients who doesn’t want to be included in the trial.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To analyze and compare the decrease in spasticity in the involved muscles between the surgical and medical arm using the modified Ashworth scores.Timepoint: 1 month, 6 months, 1 year
Secondary Outcome Measures
NameTimeMethod
To analyze and compare the improvement in functions between the surgical and medical arm using the Functional Independence Measure Instrument scale.Timepoint: 1 month, 6 months, 1 year
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