Effectiveness of outpatient rehabilitation treatment using the WelWalk for chronic cerebrovascular disease patients

JRCT ID: jRCTs042230079

Registered date:07/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Stroke
• Date of first enrollment: 09/01/2024
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Carry out gait training using WelWalk for 60 minutes a day, twice a week for 10 weeks in addition to conventional exercise therapy

Outcome(s)

• Primary Outcome: Change in walking speed and Life-Space Assessment before and after intervention

Secondary Outcome

1.Walking speed
2.Spatio-temporal parameters for walking
3.Muscle strength of Quadriceps
4.Stroke Impairment Assessment Set-motor score(lower limb), sensory(lower limb), trunk function, muscle tone(lower limb)
5.Barthel index(BI)
6.Functional Independence Measure(FIM)
7.Vitality Index
8.Life-Space Assessment
9.Gait Ability Assessment for hemiplegics(GAA)
10.Cognitive-related Behavioral Assessment(CBA)
11.Frenchay Activities Index(FAI)
12.SF-8
13.Subjective evaluation before and after Welwalk intervention(Global rating of change scales)
14.Retrospective investigation of assessment results recorded in past care records
15.Record of walking practice using Welwalk

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Participants who gave written consent to participate in this study from themselves or their proxy consents
2.Stroke participants participate with outpatient treatment 2 or more times at Fujita Health University Nanakuri Memorial Hospital
3.Participants who can gait exercise (regardless of the use of a walking aid)
4.Participants who require assistance with walking or whose walking speed is less than 0.8 km/h
5.Participants body weight >= 35 kg and < 95 kg
6.Participants > 140 cm and < 190 cm
7.Participants are more than 40 years old

Exclude criteria

1.Participants with uncontrolled hypertension or hypotension
2.Participants with uncontrolled cardiac or respiratory dysfunction
3.Participants with pacemakers
4.Participants with susceptible fractures of the legs or spine (such as severe osteoporosis)
5.Participants with ectopic ossification of the lower extremities leading to limited range of motion
6.Pregnant and possibly pregnant participants
7.Participants who have an infection and require isolation
8.Participants scheduled for antispasticity therapy with botulinum toxin preparations to the lower extremities during the study period
9.When practicing wearing robot legs, participants who have difficulty wearing robot legs due to excessive or deformed lower limbs or pressure sores
10.Other participants judged inappropriate by the attending physician, investigator, subinvestigator, or subinvestigator

Related Information

• Primary Sponsor: Otaka Yohei
• Source(s) of Monetary Support: TOYOTA MOTOR CORPORATION