The effects of a walking assistant robot "RE-Gait"

JRCT ID: jRCTs062180099

Registered date:25/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cerebrovascular disease
• Date of first enrollment: 07/08/2017
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Walking exercise with the walking assistant robot "RE-Gait"(2-4 weeks, 8-14 times x 20 minutes per week) or Walking exercise without the walking assistant robot (2-4 weeks, 8-14 times x 20 minutes per week)

Outcome(s)

Primary Outcome

1.Walking speed, Stride length
2.Joint angle of walking (hip, knee, foot)
3.Reciprocal inhibition
4.Somatosensory evoked potential
5.Cortico-muscular coherence

Secondary Outcome

1.Number of occurrences of adverse events
2.Feeling of fatigue and impression of using RE-Gait

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1.Persons with motor paralysis in one side limbs.
2.Persons who are considered to have a small risk of recurrence of the stroke (one or more months have passed since the onset of stroke).
3.Persons who do not have respiratory or cardiovascular disease
4.Persons with mild paralysis of lower limbs (Brunnstrom's recovery stage III or higher).
5.Persons who can walk continuously for about 1 km at the monitoring level (canes and walking aids can be used).
6.Persons who do not allow limitation of the range of motion of the ankle joint.
7.Persons who can participate in walking practice (three times a week, one month).
8.Persons aged 20 to 80 at the time of consent.
9.Person who obtains consent in writing on participation of this study.

Exclude criteria

1.Persons with severe paralysis of lower limbs (Brunnstrom's recovery stage II or less).
2.Persons who have serious diseases other than the relevant diseases or diseases to be indicated for surgery.
3.Person who was judged to be difficult to participate in research from his / her own physician.
4.Women who are lactating, pregnant or may become pregnant.
5.Others who judged inappropriate by the research staffs.

Related Information

• Primary Sponsor: Mitsuhara Takafumi
• Secondary ID(s): UMIN000028587