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Pilot study using HAL lower limb type (2S size) for children with developmental non-progressive motor dysfunction such as cerebral palsy (Pilot study using HAL for children with developmental non-progressive motor dysfunction)

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

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Seven subjects who met the inclusion criteria were enrolled in this study, and all completed the study protocol. The cohort comprised three boys and four girls with a mean age of 8.4 years (range, 6 to 10 years), a mean height of 120.1 cm (range, 107.0 to 127.5 cm), and a mean weight of 25.9 kg (range, 16.2 to 39.4 kg). Diagnoses included cerebral palsy in four patients, Ewing's sarcoma of the spine in one patient, hypoxic-ischemic encephalopathy in one patient, and spina bifida in one patient. According to the Gross Motor Function Classification System (GMFCS), two patients were level II, two were level III, and three were level IV. Three participants were outpatients and the remaining four were hospitalized.

Although the target sample size of 15 was not reached, seven children with developmental non-progressive motor disorders such as cerebral palsy were participated. This study aimed to conduct an exploratory assessment of the safety and feasibility of the HAL Medical Lower Limb Type (Size 2S) in motor postural disorders related to standing and walking for pediatric patients. In terms of safety, no serious adverse events, such as falls or tumbles, were observed. Furthermore, we were able to confirm the feasibility of the research protocol, leading to the Investigator-initiated clinical trial of a wearable cyborg HAL voluntary controlled by bioelectrical signals to verify the effectiveness of growth motor function for motor postural disorders related to standing and walking for pediatric patients with cerebral palsy: A multicenter, randomized, parallel-group comparison study (LIFE-STAGE trial).

No diseases or serious adverse events occurred in this study.

The primary outcome measure, GMFM-88, increased from 65.51 to 66.72, but no significant difference was observed (p=0.07). For secondary outcome measures, the GMFM-66 showed a significant improvement from 53.63 to 54.96 (p=0.04). Additionally, COPM satisfaction increased significantly from 3.3 to 5.1 (p=0.04). However, the step length of 10m walk test increased from 0.32 to 0.34 (p=0.25), the 2- minute walk distance increased from 59.1 to 62.8 (p=0.54), The GMFM-D domain score increased from 41.03 to 44.69 (p=0.17), GMFME domain increased from 29.96 to 30.75 (p=0.55), and COPM performance level increased from 3.7 to 5.3 (p=0.06), but no significant differences were observed.

Seven children participated in this study, and all subjects completed the study protocol. No serious adverse events occurred, confirming the safety and feasibility of continuous intervention using HAL (size 2S). While no significant difference was observed in the primary outcome measure (GMFM-88), significant improvements were demonstrated in the secondary outcome measures GMFM-66 and COPM satisfaction scores. Furthermore, the change in GMFM-66 exceeded the MCID (GMFM-66 amount of change: 1.3, MCID: 0.8).

Mar. 31, 2026

Nov. 03, 2023

https://doi.org/10.3389/fneur.2023.1255620

Yes

The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.

https://jrct.mhlw.go.jp/latest-detail/jRCTs032200037

Marushima Aiki

University of Tsukuba Hospital

2-1-1, Amakubo, Tsukuba, Ibaraki

aiki.marushima@md.tsukuba.ac.jp

Marushima Aiki

University of Tsukuba Hospital

2-1-1, Amakubo, Tsukuba, Ibaraki

+81-29-853-3220

aiki.marushima@md.tsukuba.ac.jp

Complete

May. 26, 2020

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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.

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.

Both

Cerebral palsy, spina bifida, cerebrovascular disorder, and cerebrospinal cord injury

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.

The 88 items of gross motor function measure (GMFM-88)

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

+81-29-853-3914

April. 06, 2020

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