HAL for PwH Study

JRCT ID: jRCTs052220076

Registered date:16/08/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hemostatic Disorders
• Date of first enrollment: 16/08/2022
• Target sample size: 24
• Study type: Interventional
• Intervention(s): Rehabilitation therapy using HAL

Outcome(s)

• Primary Outcome: Changes in pain assessed by Visual Analog Scale during flexion-extension exercises after a standard rehabilitation program and during subsequent HAL-assisted or unassisted flexion-extension exercises.

Secondary Outcome

1)mount of change in the Japanese version of TSK after the first and second rehabilitation sessions from the time of patient enrollment.
2)Satisfaction with rehabilitation, fatigue of rehabilitation, and following parameters before and after the rehabilitation program: pain, fear of pain due to movement, muscle output, joint range of motion, stance stability, gait stability, and thermal information on body surface

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

1)Patients with hemostatic disorders who are treated at a Nara Medical University Hospital.
2)Patients with pain and physical function impairment who require rehabilitation therapy targeting elbow, knee, or ankle joint.
3)Patients between 12 and 85 years old.
4)Patients with written consent.

Exclude criteria

1)Patients who are unable to fit HAL due to their severe joint deformities.
2)Post-arthrodesis patients.
3)Patients with fragile skin and potential skin damage due to electrode attachment.
4)Patients with implanted pacemakers or ICDs.
5)Patients with cardiovascular or respiratory diseases that may worsen with rehabilitation therapy.
6)Patients who have difficulty understanding explanations and instructions.
7)Patients with moderate or severe involuntary movements, ataxia, and postural reflex disorders.
8)Patients with severe contractures or spasticity.
9)Patients with difficulty in hemostatic treatments, such as patients with high titer inhibitory antibody or patients with inhibitory antibody who previously demonstrated poor response to antibody-neutralizing treatment.
10)Other patients determined to be inappropriate by the doctors.

Related Information

• Primary Sponsor: Shima Midori
• Source(s) of Monetary Support: CYBERDYNE, INC,Nara Medical University