Skip to content

Effects of Upper Limb HAL on Patients with Acute Stroke

The Effect of HAL Medical Single Joint Type on Sense of Agency and Paretic Arm Use in Patients with Acute Stroke

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1062250035
Enrollment
50
Registered
2025-07-16
Start date
2025-07-16
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 paradlysis, rehabilitation

Interventions

In this study, subjects will be randomly assigned to the intervention and control groups and will receive 2 weeks of upper extremity functional training. The subjects will be randomly assigned to an i
Robotics

Sponsors

MORIGAKI RYOMA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Stroke patients with upper limb motor paralysis admitted to Tokushima University Hospital. Age less than 80 years, first stroke, Brunnstrom recovery stage II-IV, no cognitive impairment (Mini-Mental State Examination: MMSE >24), no skin disease or skin fragility at the site of application, no orthopedic disease or neuromuscular disease that inhibits upper limb movement Patients will be enrolled sequentially if they have no history of orthopedic or neuromuscular disease that interferes with upper extremity movement, have detectable biceps and triceps biopotential signals, are in stable general condition, and have controlled comorbidities.

Exclusion criteria

Exclusion criteria: When consent was not obtained from the patient or surrogate. If the lesion is under the tent. If a pacemaker is inserted. If the patient is diagnosed with subarachnoid hemorrhage. The patient does not have the bio-potential signals necessary to operate the HAL medical single joint type. Body size is not suitable for HAL medical single-joint type (body weight >100kg). Patient has an orthopedic disease, neuromuscular disease, or other disease that interferes with the movement of the upper limb. Other cases in which participation in this study is deemed inappropriate.

Design outcomes

Primary

MeasureTime frame
The primary endpoint in this study was a questionnaire used to assess the sense of exercise ownership.12 The questionnaire consisted of four items with factor loadings from the discomfort factor and six items with factor loadings from the sense of ownership factor. The questionnaire consists of four items with factor loadings from the discomfort factor and six items with factor loadings from the initiative factor, The total score is calculated by correcting the scores of the reversed items. In this study, this questionnaire will be used to conduct evaluations at four time points: pre-intervention, 2 weeks, 6 months, and 12 months after the intervention. The evaluation will be fully explained and self-administered by a physician or occupational therapist who is unaware of the assignment, to minimize evaluation bias.

Secondary

MeasureTime frame
Secondary endpoints will include the following: motor function, activity of the paralyzed upper extremity, and cognitive and higher brain function,cognitive and higher brain function, and brain activity.

Contacts

Public ContactOhmae Hiroshi

Tokushima University Hospital

oomae.hiroshi@tokushima-u.ac.jp+81-886-32-9464

Outcome results

None listed

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