Effect of Gait Relearning Robot for Children with Cerebral Palsy

JRCT ID: jRCTs052200019

Registered date:28/05/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Cerebral palsy
• Date of first enrollment: 11/06/2020
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Gait Training: walking with the device for 20min/day and 4 times a week. The training phase takes 4week.

Outcome(s)

• Primary Outcome: 5.5 meter walk test, Number of steps

Secondary Outcome

1) Gross Motor Function Measure (GMFM) Dimensions D,E
2) Pediatric Evaluation of Disability Inventory (PEDI)
3) Modified Ashworth scale
4) Kinematic gait analysis
5) Kinematic data evaluated by the sensors of the robot
6) Electromyography
7) Questionnaires for the parents
8) Questionnaires for the patients

Key inclusion & exclusion criteria

• Age minimum: >= 6age old
• Age maximum: <= 18age old
• Gender: Both

Include criteria

1. Pediatric with GMFCS level I-III.
2. Individuals over 110cm in height, and over 20kg in weight.
3. Individuals who can walk independently using walking aids (canes, walkers, AFO, etc.) for more than 20 minutes outside the house.
4. Individuals who can understand the instructions during the gait training.

Exclude criteria

1. Individuals who have high cognitive decline and higher brain dysfunction, and it is difficult to understand or agree with the research explanation.
2. Individuals with movement restriction due to respiratory, cardiovascular, urological and digestive diseases.
3. Individuals with pain due to orthopedic or other neurological diseases which limit gait.
4. Individuals who have received the treatment to reduce spasticity (such as BT-X, tendon lengthening surgery or spasticity control surgery) within 3 months.

Related Information

• Primary Sponsor: Yoshida Takeshi
• Secondary Sponsor: Ohata Koji
• Source(s) of Monetary Support: Honda R&amp;D Innovative Research Excellence