Safety and feasibility of Medical Care Pit for stroke patients

JRCT ID: jRCTs032180020

Registered date:01/10/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Stroke patients (Cerebral infarction or cerebral hemorrhage)
• Date of first enrollment: 26/11/2018
• Target sample size: 10
• Study type: Interventional
• Intervention(s): In addition to traditional rehabilitation, gait assessment and training using Medical Care Pit twice a week for a total of 4 times (2 weeks)

Outcome(s)

• Primary Outcome: Feasibility (Completion rate of walking training for 2 weeks using Medical Care Pit)

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Hada Yasushi
• Source(s) of Monetary Support: Japan Science and Technology Agency