Safety and feasibility of Medical Care Pit for stroke patients

Phase 2

• Conditions: Stroke patients (Cerebral infarction or cerebral hemorrhage)

• Registration Number: JPRN-jRCTs032180020
• Lead Sponsor: Hada Yasushi

Brief Summary

Gait measurement and walking practice on the treadmill could be carried out safely. This was important from the viewpoint of establishing an objective evaluation method for gait and its application to critically sever patients. The device was excellent in that it could easily calculate the stride, the number of steps, and the walking distance and feed back to the therapist and patient in real time. However, there is a need for further improvements in both hardware and software.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-01
• Study Completion: 2019-02-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Stroke patients who declining standing and/or walking ability (Cerebral infarction or cerebral hemorrhage).
Patients who satisfy all the following criteria are targeted.
1. The patient who the agreement document is possible by put a substitute writer.
2. The patient who is 20 years age or older at consent acquisition.
3. The patient who is less than six months after the onset by stroke.
4. Patient with reduced standing and walking ability. (Patient with a score of 0 to 4 on the Functional Ambulation Category).
5. Patient whose height is about 140 to 190 cm and whose body weight is about 40 to 120 kg.
6. The patient who is available hospitalization during study period.

Exclusion Criteria

Patient who conflict with one of the following criteria are excluded and not subject to this clinical study.
1. The patient who investigator/subinvestigotor recognized the following symptom.
1) The patient who have akinesia, rigidity, and ataxia with high grade.
2) The patient whom rehabilitation cannot be performed to in the training room.
3) The patient who cannot understand the command and have communication.
4) The patient who has muscle spasm, deformity and contracture on the lower extremity with high grade.
5) Patient using active implantable medical devices such as cardiac pacemakers.
6) Pregnant women.
2. The patient who MD judged it no good to participate to the clinical trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility (Completion rate of walking training for 2 weeks using Medical Care Pit)

Secondary Outcome Measures

Name	Time	Method
Gait parameter<br>Gait assessment<br>Adverse effects<br>Functional Ambulation Category<br>Burden of therapists during training and assessment with Medical Care Pit<br>Satisfaction level of therapists and patients during training and assessment with Medical Care Pit<br>Modified Borg scale<br>Actual time and person during preparation, wearing, and gait analysis with Medical Care Pit<br>Fugl-Meyer Assessment for lower limbs