Evaluation of low cost, customized orthoses for improvement of upper limb function in children with congenital hemiparesis

ORGAN - LOW COST BIOMECHATRONIC REHABILITATIVE SOLUTIONS FOR CHILDREN WITH CONGENITAL HEMIPARESIS - ORGAN

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/10/015924

Enrollment

Registered

2018-10-08

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-29

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

Conditions

Health Condition 1: G00-G99- Diseases of the nervous system

Interventions

Intervention1: Biomechatronic rehabilitation: Customized Orthoses/Exoskeleton for upper limb Control Intervention1: Not applicable as a single arm study.: Not applicable as a single arm study.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnosis of Hemiplegic cerebral palsy 2. Willing for follow-up during study period 3. Gross Motor Function Classification System Level 1 or 2

Exclusion criteria

Exclusion criteria: 1. Seizures uncontrolled 2. Parents declined consent 3. Child with hearing or visual impairment affecting participation 4. Planning for other intervention during intervention period eg. BOTOX/ Orthopedic procedure

Design outcomes

Primary

Measure	Time frame
1. Functional skills of upper limb a. Change in Goal attainment scaling/Other upper limb functional scale b.Change in Modified Ashworth Scale of affected upper limb c. Acceptability of provided Orthoses d. Withdrawal/compliance issues Timepoint: Baseline, 3 and 6 months	—

Secondary

Measure	Time frame
Acceptability of provided OrthosesTimepoint: baseline day 1, day 2, 2 week, 4 week, 8 week, 12 week, 16 week, 20 week, 24 week	—

Countries

India

Contacts

Public ContactDr Jitendra Kumar Sahu

CSIR-Central Scientific Instruments Organisation

neel5278@gmail.com

Outcome results

None listed

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