Can robotic technology assist children with cerebral palsy after botulinum toxin injection?

Not Applicable

Recruiting

• Conditions: Lower limb hypertonia; Equinus; Neurological - Other neurological disorders; Gait abnormalities; Cerebral Palsy; Physical Medicine / Rehabilitation - Physiotherapy; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12621000605897
• Lead Sponsor: Womens and Childrens Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-20
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Diagnosed with cerebral palsy (CP).
Gross Motor Function Classification System (GMFCS) Level I-IV.
Dynamic hypertonia in lower limb muscles with functional impact not responsive to therapy input alone.
Able to follow instructions, participate in 45 minutes of therapy.
Able to communicate pain, perceived level of exertion.

Exclusion Criteria

Body weight less than 15kg or greater than 135kg.
Femur length less than 23cm or greater than 47cm.
Unable to maintain standing >20minutes.
Knee flexion contracture >15degrees.
Knee valgus >40degrees.
Orthopaedic surgery (lower limb) <9months (soft tissue); <18months (bony)
Botulinum Toxin (type A) injection in past 4 months.
Uncontrolled siezures.
Weight-bearing restrictions.
Behavioural problems.
Requires serial casting.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of effect. Time (in days) from botulinum toxin injection to functional deterioration that necessitates re-injection, assessed using Goal Attainment Scaling (GAS) responses from weekly text messages. A GAS score of -1 or below is considered functional deterioration.[Weekly, from week 1 after injection until 'time-to-event'. 'Time-to-event' will vary for the individual post-injection.]