The influence of robot-assisted gait training using the Hybrid Assistive Limb (HAL) system on the effectiveness of a multimodal therapy concept in children and adult patients with cerebral palsy
- Conditions
- G80Cerebral palsy
- Registration Number
- DRKS00020275
- Lead Sponsor
- Klinik für manuelle Therapie
- Brief Summary
Robot-assisted gait training (RAGT) provides a task-based support of walking using exoskeletons. Evidence shows moderate, but positive effects in the therapy of patients with cerebral palsy (CP). This study investigates the impact of RAGT on walking speed and gait parameters in pediatric CP patients. Thirty subjects (male = 23; female = 7), with a mean age of 13.0 ± 2.5 (9–17) years, and with spastic CP, were recruited. The intervention group (n = 15) underwent six 20-minute RAGT sessions with the Hybrid Assistive Limb (HAL) during an 11-day hospital stay. Additionally, a therapy concept including physiotherapy, physician-performed manual medicine, massage and exercise therapy was provided. The control group (n = 15) was treated with the therapy concept only. The outcome was based on a 10-Metre Walking Test (10MWT), 6-Minute Walking Test (6MWT), Gross Motor Function Measure (GMFM-88) and lower extremities passive range of motion. The intervention group achieved a mean increase in walking speed in the 10MWT (self-selected walking speed SSW) of 5.5 s (p = 0.378). There were no significant differences between the groups in the 10MWT (max) (p = 0.123) and the 6MWT (p = 0.8). Changes in the GMFM (total) and in the dimension standing and walking, running and jumping (D + E) showed clinically relevant significant results (p = 0.002 and p = 0.046). RAGT as a supplement to an inpatient therapy stay appears to have a positive, yet not significant impact on the gait parameters of pediatric CP patients as well as motivating them to practice walking. Further studies with adapted study designs are needed to evaluate different influencing factors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 41
Spastic cerebral palsy (bi- or tetraparesis),
8-18 or >18 years, GMFCS II and III, 14m
Ability to walk, adequate verbal or non-verbal information / expression of pain, instructions to follow, written and verbal consent from parents
Surgical interventions on muscles, tendons, bones of the hip, knee and ankle joints within the last 6 months before the study, botox therapy in the last 3 months, other assistive walking support training methods with robots e.g. Lokomat within the last 6 months before the start of the study, breaks, skin lesions, circulatory disorders, unable to follow instructions
Manufacturer exclusion: Height<150cm weight: <40kg, thigh length: <355-375> mm, lower leg length <340-375 mm>, hip width <310-350 mm>
If the size does not fit, body measurements are sufficient, the HAL system can be used
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method WHAT: difference in gait speed (m / s)<br>WHEN: Beginning and end of the inpatient stay as well as in a 5 week follow up<br>HOW: 10m walking test
- Secondary Outcome Measures
Name Time Method WHAT: Increase the walking distance<br>WHEN: Beginning and end of the inpatient stay as well as in a 5 week follow up<br>HOW: 6 minute walk test<br>WHAT: Improve joint mobility<br>WHEN: Beginning and end of the inpatient stay as well as in a 5 week follow up<br>HOW: measuring the ROM of hip, knee and ankle