Skip to content

Safety and feasibility of Medical Care Pit for stroke patients

Safety and feasibility study of Medical Care Pit walking support for stroke patients - Safety and feasibility study of Medical Care Pit for stroke patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032180020
Enrollment
10
Registered
2018-10-01
Start date
2018-11-26
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke patients (Cerebral infarction or cerebral hemorrhage)

Interventions

In addition to traditional rehabilitation, gait assessment and training using Medical Care Pit twice a week for a total of 4 times (2 weeks)

Sponsors

Hada Yasushi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Feasibility (Completion rate of walking training for 2 weeks using Medical Care Pit)

Secondary

MeasureTime frame
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

Contacts

Public ContactYasushi Hada

University of Tsukuba Hospital

y-hada@md.tsukuba.ac.jp+81-29-853-3900

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026