A study of the short-term gait improvement effect using a biological signal reaction type motor function improvement device in patients with Parkinson's disease.

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-jRCTs052220012
• Date of registration: 22/04/2022
• Prospective Registration: No
• Primary sponsor: Kohara Nobuo
• Public title: A study of the short-term gait improvement effect using a biological signal reaction type motor function improvement device in patients with Parkinson's disease.
• Scientific title: A study of the short-term gait improvement effect using a biological signal reaction type motor function improvement device for gait instability in pati ents with Parkinson's disease. a randomized controlled trial
• Date of first enrolment: 01/04/2022
• Target sample size: 30
• Recruitment status: Complete
• URL: https://jrct.niph.go.jp/latest-detail/jRCTs052220012
• Study type: Interventional
• Study design: randomized controlled trial, open(masking not used), active control, parallel assignment, treatment purpose
• Phase: N/A

Contacts

• Name: Nobuo Kohara
• Affiliation: Kobe City Medical Center General Hospital

• Name: Utako Shirono
• Affiliation: Kobe City Medical Center General Hospital

Key inclusion & exclusion criteria

Inclusion criteria: 1)Those who have been diagnosed with clinically established or clinically probable cases according
to the clinical diagnostic criteria for Parkinson's disease by the Movement Disorder Society (MDS).
2)Hoehn-Yahr Scale stage III
3)Those who have not changed the type and dos e of Parkinson's drug before 4 weeks of the date o f consent acquisition and have no plans to change it while participating in clinical research.
4)Those who do not have a clear wearing-off phe nomenon.
5)Those who are judged by the doctor that their g eneral condition is stable and that standing / walki ng training can be carried out.
6)Those who can stand up and sit and walk 10 m or more without assistance (regardless of the use of assistive devices).
7)Those who are 20 years old or older at the time of consent
8)Those who have obtained the document conse nt of the subject.
9)Those who meet the following conditions descri bed in the HAL package insert
a)Weight 40-100kg
b)Those who can wear HAL with a height of about 150 to 190 cm or a body size such as thigh length, lower leg length, and waist width.
10) Those who can about21-day rehabilitation hos
pitalization for PD.
Exclusion criteria: 1)Those who the doctor judges to be inappropriat e, such as improper standing and walking training 2)Those who have difficulty wearing HAL due to p hysical deformation, etc.
3)Those who have difficulty in attaching electrode s due to skin diseases, etc.
4)Those who are pregnant
5)Those who have a cognitive function test (MMS
E) of 23 points or less.
6)In addition, those who are judged to be inappro priate for conducting this research by the principal investigator or the other investigator.

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

Health Condition(s) or Problem(s) studied

Parkinson's disease
Parkinson's disease

Parkinson's disease

Intervention(s)

The normal rehabilitation group and the HAL grou p are assigned 1: 1 and the normal rehabilitation g roup is subjected to normal walking training, and t he HAL group is subjected to walking training by H
AL.

Primary Outcome(s)

2 minutes walking distance

Secondary Outcome(s)

10m walking time Walking speed Walking rate Stride
SPPB ADL FIM
UPRDS Part 3 ESAS
GSES
Posture tilt of body axis Timed Up and Go Test TUG

Ethics review

Status: Approval
Approval date:
Contact:

[e-mail]

Kobe city medical center general hospital certified review bo ard

[phone]

[e-mail]

Results

• Results available: Yes
• Date Posted: 06/02/2023
• Date Completed: 20/12/2022