Cerebral palsy Nervous System Diseases
Conditions
Interventions
The intervention phase of this study is FES, a battery-powered, pocket electrical device combined with a foot switch to allow precisely timed muscle stimulation while walking. This will be compared to
Sponsors
University of Plymouth
Torbay Medical Research Fund
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of spastic CP (GMFCS level I-III), affecting one or more muscle groups in both lower limbs, and aged 8 - 18 years 2. The ability to follow simple instructions 3. The ability to adhere to the FES protocol 4. The ability to walk 20 metres of more with or without a walking frame
Exclusion criteria
Exclusion criteria: 1. Dystonic or Athetoid CP as the sole presentation (CYP with dystonia / athetosis co-occurring with a spastic presentation can be included) 2. Selective dorsal rhizotomy or Multi level orthopaedic surgery within the last 6 months 3. Soft tissue surgery in lower limbs in the last 6 months 4. Anti-spasticity botulinum toxin injections within 3 months 5. Moderate to Severe Cognitive Impairment and/or Learning difficulties that may limit the use of FES consistently or appropriately 6. Poorly controlled epilepsy 7. Bilateral Fixed Knee Flexion deformities > 10 degrees 8. Bilateral contractures of the tendon Achilles which means they are unable to achieve plantigrade (90 degrees) in both ankles by passive movement when the knee is bent. (please note that CYP with one contracted tendon Achilles may still be considered appropriate for FES intervention) 9. CYP with a Cardiac Pacemaker 10. CYP with a malignant Tumour in the area that FES stimulation is taking place I.e., the thigh or lower leg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured at week 0 (prior to starting Usual’ Physiotherapy), week 8 (post ‘Usual’ Physiotherapy), week 10 (prior to starting FES intervention) and week 19 (post FES intervention) 1.Popliteal Angle and Hamstring Spasticity (Modified Tardieu Scale) 2.Passive Ankle Range of Motion and Gastrocnemius spasticity (Modified Tardieu Scale) 3.Duncan Ely and Rectus Femoris spasticity (Modified Tardieu Scale) 4.Passive Hip Flexor Range of Motion (Thomas test) 5.Tibialis Anterior Strength (Hand- Held Dynamometer) 6.Quadriceps strength (Hand- Held Dynamometer) 7.The Goal Questionnaire 8.Extensive Walking Assessment – Measuring knee flexion at Initial contact and Midstance using an Electro goniometer. 9.Stairs Assessment - Measuring knee flexion using an Electro goniometer 10.SCALE tool - Selective Control Assessment of the Lower Extremity (SCALE) Assessed at Week 0 only 11.Foot Posture established with the CYP in standing and barefoot. Hind foot position whilst weight bearing and the presences of a midfoot break will be recorded using the CPIP manual as a guide | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessed weekly during ‘Usual Care’ and ‘FES intervention’ from Week 1 – 18 1. Self-report Neuro-QOL paediatric fatigue form 2. 12- Item Walking Scale (Walk 12-G) 3. FES Activity Logger - This data includes the number of steps taken and the duration of use in HH:MM 4. Tibialis Anterior Strength (Hand- Held Dynamometer) 5. Quadriceps strength (Hand- Held Dynamometer) 6. Hamstring, Gastrocnemius and Rectus Femoris Spasticity (Modified Tardieu Scale) 7. Weekly Walking assessment - Measuring knee flexion at Initial contact and Midstance using an Electro goniometer 8. Weekly Stairs Assessment - Measuring knee flexion using an Electro goniometer | — |
Countries
England, United Kingdom
Contacts
Public ContactHarriet Hughes
Outcome results
None listed