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Does the use of a robotic rehabilitation trainer change quality of life, range of movement and function in children with cerebral palsy?

A prospective, single-arm, pre-post trial to investigate whether quality of life, range of movement (ROM), spasticity and function, in children with cerebral palsy (GMFCS IV-V) can be affected using a robotic rehabilitation trainer for 30 minutes, 4 times a week for 6 weeks

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN92095509
Enrollment
25
Registered
2022-03-16
Start date
2020-02-10
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Cerebral palsy Nervous System Diseases Cerebral palsy

Interventions

This trial will not use randomisation due to it being a single-arm pre-post intervention using a convenience sample. All participants in the study will receive their usual level of physiotherapy care

Sponsors

Whittington Health NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Children aged 5-18 years 2. Attends the special school (primary and secondary) 3. Diagnosis of CP classified at level IV-V 4. Parents/legal guardians give consent to partake in the trial

Exclusion criteria

Exclusion criteria: 1. Any child who has had orthopaedic surgery in the last year to their lower limbs 2. Any child who meets the criteria but has had botox in their lower limbs within 3 months of the trial 3. Any child who meets the criteria however is younger than 5 or older than 18 years 4. Any contractures that don’t allow access to the Innowalk Pro 5. Any orthopaedic/medical advice not to stand 6. Fixed flexion deformity of the hip >40 degrees, knee >50 degrees 7. Severe scoliosis, windswept deformity, contractures or other deformities interfering with the positioning of a user in the Innowalk Pro 8. Epilepsy not controlled by medication 9. Lack of head control which is not possible to support in the Innowalk Pro 10. Skin lesion/pressure areas in the contract areas of the padding/contact with the device 11. Osteoporosis with previous or suspected spontaneous fractures of the lower extremities 12. Lack of compliance of acceptance of dynamic standing 13. Intolerance, pain or not able to cooperate or be positioned adequately within the Innowalk Pro

Design outcomes

Primary

MeasureTime frame
Quality of life (QOL) measured using the CPCHILD questionnaire for parents and caregivers, before (-3/5 days) the intervention starts, immediately when the intervention ends after 6 weeks, and repeated 6 weeks and 3 months following the completion of using the Innowalk pro

Secondary

MeasureTime frame
1. Range of movement of hip extension, ankle dorsiflexion with knee extended and flexed, knee extension measured using a goniometer, immediately pre and post the intervention period of 6 weeks and repeated at 6 weeks and 3 months on completion of using the Innowalk Pro 2. Popliteal angle measured using a goniometer immediately pre and post the intervention period of 6 weeks and repeated at 6 weeks and 3 months on completion of using the Innowalk Pro 3. Hamstring, soleus, gastrocnemius and rectus femoris spasticity measured using the Modifed Tardieu Scale immediately pre and post the intervention period of 6 weeks and repeated at 6 weeks and 3 months on completion of using the Innowalk Pro 4. Perceived function measured using Goal Attainment Scale, before (-3/5 days) the intervention starts, immediately when the intervention ends after 6 weeks, and repeated at 6 weeks and 3 months following the completion of using the Innowalk pro

Countries

England, United Kingdom

Outcome results

None listed

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