Effect of Gait Relearning Robot for Individuals After Stroke

JRCT ID: jRCTs052200011

Registered date:12/05/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Gait disorder after stroke
• Date of first enrollment: 02/09/2020
• Target sample size: 72
• Study type: Interventional

Intervention(s)

"Robot Assist Gait Training (RAGT) group"
Conventional training; conduct stretching, muscle strengthening, balance training as necessary on 40min/day for 1week. Robot Assist Gait Training; walking with Robot on 20min/day for 1week.
"Control group"
Conventional training; conduct stretching, muscle strengthening, balance training as necessary on 40min/day for 1week.
Conventional gait training; walking without Robot on 20min/day for 1week.

Outcome(s)

• Primary Outcome: Ten meter walk test

Secondary Outcome

1)Fugl-Meyer Assessment on Lower Extremity
2)Function Independent Measure Walk item
3)Modified Ashworth scale
4)Functional Ambulation Categories
5)Berg Balance Scale
6)Timed Up and Go test (TUG)
7)kinematic gait analysis
8)Electromyography
9)questionnaires for therapist
10)questionnaires for patient

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

Include criteria

1.Individuals with hemiplegia after first stroke.
2.Individuals within 6 months after the onset of stroke.
3.Individuals who can walk independently using walking aids (canes, walkers, AFO, etc.).
4.Individuals who have walking ability that were classified Functional Ambulation Category II or more, and motor function estimated as Brunnstrom Recovery Stage II-VI.

Exclude criteria

1.Individuals who have high cognitive decline and higher brain dysfunction, and it is difficult to understand with the research explanation.
2.Individuals with movement restriction due to respiratory, cardiovascular, urological and digestive diseases.
3.Individuals with orthopedic or other neurological diseases that limit gait.
4.Individuals with a pulse at rest of 120 / min or more, diastolic blood pressure of 120 mmHg or more, systolic blood pressure of 200 mmHg or more.
5.Individuals who are receiving the rTMS or TDCS within 3 month.
6.Individuals who have received the BT-X within 3 month.

Related Information

• Primary Sponsor: Maki Takakuni
• Secondary Sponsor: Ohata Koji
• Source(s) of Monetary Support: Japan Science and Technology Agency