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

Phase 2

Recruiting

• Conditions: Stroke

• Registration Number: JPRN-jRCTs042230079
• Lead Sponsor: Sonoda Shigeru

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in walking speed and Life-Space Assessment before and after intervention

Secondary Outcome Measures

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