A investigator study to evaluate the effect of gait rehabilitation using a rehabilitation robot(Healbot T) on walking ability for stroke patients

A single-center, randomized, single blind, parallel design investigator study for finding validity items, evaluation criteria, and evaluation methods to evaluate the effect of gait rehabilitation using a rehabilitation robot(Healbot T) on walking ability for stroke patients who can walk independently or with supplementary help

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003762

Enrollment

Registered

2019-04-12

Start date

2018-12-14

Completion date

Unknown

Last updated

2019-07-17

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

Conditions

None listed

Interventions

Medical Device : All subjects receives a total of 10 walking treatment sessions for 30 minutes and 4 weeks. In this clinical trial, Functional Ambulation Classification (FAC), 10 Meter Walking (10MW)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Stroke patients over 19 years old 2. Patients who are able to board the Healbot T and more than FAC (Functional Ambulation Category) 2 3. Patients who were able to walk independently before the onset of stroke 4. Patients who wrote the agreement

Exclusion criteria

Exclusion criteria: 1. Patients who have serious difficulties in communication such as serious cognitive disorders or speech disorders. 2. Patients with limited range of motion, such as the construction of joints (patients with musculoskeletal disorders, ex: pain due to arthritis) 3. Patients who have ulcers that have bedsores, skin diseases, wounds or unhealed ulcers at the area touching cuff or harness. 4. Patients with uncontrolled hypertension or orthostatic hypotension 5. Patients who can not tolerate robot walking due to cardiovascular disease, heart failure, malignant disease, lung disease, nervous system disease, diabetes, etc. 6. Patients with severe osteoporosis who are predicted to develop fractures 7. Those who have difficulty walking because of severe deformity or pain in the legs 8. Those who are suffering from severe mental illness, neuropathy or who are significantly less cooperative 9. Pregnant women 10. Patients with severe stiffness over Modified Ashworth Scale 3 11. Patients withe tremor 12. Those who weigh more than 100 kg 13. Patients who heigh less than 150 cm or more than 185 cm 14. Patients who participated in the rehabilitation robot study for stroke and were within 30 days of the end visit 15. In addition, if the researcher judges that participation in this study is inappropriate

Design outcomes

Primary

Measure	Time frame
Functional Ambulation Classification (FAC);10-Meter Walking Test (10MW Test);Timed up and go test (TUG Test);Berg Balance Test (BBT);Modified Ashworth Scale (MAS);Motricity Index (MI)_Lower	—

Secondary

Measure	Time frame
Walking test (using optogait);EMG (electromyography)	—

Countries

Korea, Republic of

Contacts

Public ContactAnna LEE

Asan Medical Center

leeanna725@gmail.com+82-2-3010-8621

Outcome results