Pilot study using HAL lower limb type (2S size) for cerebral palsy

JRCT ID: jRCTs032200037

Registered date:26/05/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cerebral palsy, spina bifida, cerebrovascular disorder, and cerebrospinal cord injury
• Date of first enrollment: 08/07/2020
• Target sample size: 15
• Study type: Interventional
• Intervention(s): Patient receive exercise therapy with HAL lower limb type 2S size for 20 minutes once a day, and 8 to 12 times during the study period.

Outcome(s)

• Primary Outcome: The 88 items of gross motor function measure (GMFM-88)

Secondary Outcome

The 66 items of gross motor function measure (GMFM-66)
Gross motor function classification system
Maximal walking speed, step length, cadence
2 min walking distance
6 min walking distance
Gait posture, motion analysis (muscle activity)
Canadian Occupational Performance Measure (COPM)
Questionnaire for patients and families
Disease occurrence status
Test equipment failure

Key inclusion & exclusion criteria

• Age minimum: >= 5age old
• Age maximum: <= 15age old
• Gender: Both

Include criteria

Patients who meet all of the following inclusion criteria and do not meet any of the exclusion criteria are eligible for this study enrollment.

1) Patients who can give written consent by their substitute.
2) Patients aged 5-15 years.
3) Patients with Level 2-4 of GMFCS (Gross Motor Function Classification System).
4) Patients more than 1 year after onset.
5) Patients who can wear HAL lower limb type 2S size prototype and its improved equipment.
(The height is assumed to be 100-150cm, but the usage condition is not for height but for patients who fit the body size such as thigh length, lower leg length, waist width)
6) Patients who can continue hospitalization or go outpatient according to the study schedule during the study period.

Exclude criteria

Patients who conflict with one of the following criteria are excluded and not subject to this clinical study.

1) Patients who have difficulty performing voluntary limb movements according to instructions due to impaired consciousness or severe Intellectual disability.
2) Patients whose skeletal system such as osteoarthritis, spondyloarthropathy, scoliosis, etc. is severely deformed and difficult to train including joint movement or wear HAL.
3) Patients who have complications such as bleeding tendency or osteoporosis which may cause training problems.
4) Patients who cannot be put on the electrode on the skin surface due to a skin disease etc.
5) Patients who participated in other studies within 12 weeks of the start of this clinical study.
6) Patients who are considered inappropriate to participate in this study by the principal investigator or member doctors of the study.

Related Information

• Primary Sponsor: Marushima Aiki
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development