UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062661 |
|---|---|
| Receipt number | R000071728 |
| Scientific Title | Effects of Forward-Resistance Walking Using a Body Weight Support Walker on Hip Extension Angle During Gait in Patients After Unilateral Total Hip Arthroplasty |
| Date of disclosure of the study information | 2026/08/23 |
| Last modified on | 2026/08/23 14:06:25 |
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Basic information
Public title
Effects of Forward-Resistance Walking Using a Body Weight Support Walker on Hip Extension Angle During Gait in Patients After Unilateral Total Hip Arthroplasty
Acronym
Effects of Forward-Resistance Walking Using a Body Weight Support Walker on Hip Extension Angle During Gait in Patients After Unilateral Total Hip Arthroplasty
Scientific Title
Effects of Forward-Resistance Walking Using a Body Weight Support Walker on Hip Extension Angle During Gait in Patients After Unilateral Total Hip Arthroplasty
Scientific Title:Acronym
Effects of Forward-Resistance Walking Using a Body Weight Support Walker on Hip Extension Angle During Gait in Patients After Unilateral Total Hip Arthroplasty
Region
| Japan |
Condition
Condition
After unilateral total hip arthroplasty
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate changes in hip extension angle during gait before, during, and after forward-resistance walking using a body weight support walker in patients after unilateral total hip arthroplasty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximum hip extension angle of the operated side during gait is assessed under the following three conditions: (1) usual walking before forward-resistance walking, (2) forward-resistance walking using a body weight support walker, and (3) usual walking immediately after forward-resistance walking.
Key secondary outcomes
Gait speed and step length (assessed under the same three conditions as the primary outcome).
Rating of perceived exertion during forward-resistance walking using a body weight support walker (Modified Borg Scale; assessed immediately after forward-resistance walking).
Pain in the operated hip during gait (Numerical Rating Scale: NRS; assessed under the same three conditions as the primary outcome).
Passive hip extension range of motion of the operated side (assessed before gait measurement).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The intervention is conducted on a single day. Participants perform three 10-m trials of forward-resistance walking using a body weight support walker. The body weight support function of the walker is not used. The forward-resistance function can be switched on or off, but the amount of resistance cannot be adjusted. Before forward-resistance walking using the body weight support walker, participants perform three 10-m trials of usual walking, followed by another three 10-m trials of usual walking immediately after forward-resistance walking.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients hospitalized at Maki Hospital who are 1 to 6 weeks after unilateral total hip arthroplasty.
2.Individuals who have received a sufficient explanation of the study and provided written informed consent.
3.Individuals who are able to walk independently or with a cane.
4.Individuals who are judged by the attending physician and physical therapist to be able to safely perform the walking tasks required in this study.
Key exclusion criteria
1.Patients in the immediate postoperative period after total hip arthroplasty who are unable to walk safely.
2.Individuals who are unable to complete the walking distance required in this study due to pain.
3.Individuals with an orthopedic or neurological condition of the non-operated lower limb that clearly affects gait (e.g., previous joint replacement, osteoarthritis requiring surgery, previous proximal femoral fracture, hemiplegia due to stroke, or Parkinson's disease).
4.Individuals who have difficulty understanding the study or following instructions due to cognitive impairment or higher brain dysfunction.
5.Individuals who are judged to be unable to walk safely due to neurological disease, severe cardiovascular disease, respiratory disease, or other conditions.
6.Individuals who are otherwise judged by the attending physician to be unsuitable for participation in the study.
7.Individuals who do not provide consent for video recording conducted in this study.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Tajika |
Organization
Gunma University
Division name
Graduate School of Health Sciences
Zip code
371-8514
Address
3-39-22 Showa-machi, Maebashi, Gunma, Japan
TEL
027-220-8945
tajika@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Shogo |
| Middle name | |
| Last name | Watanabe |
Organization
Maki Hospital
Division name
Department of Rehabilitation
Zip code
370-0075
Address
71-1 Tsukunawamachi, Takasaki, Gunma, Japan
TEL
027-361-8411
Homepage URL
syougo.watanabe110359@gmail.com
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Tsuyoshi Tajika
Funding Source
Organization
Gunma University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Human Research Ethics Committee
Address
3-39-15 Showa-machi,Maebashi,Gunma 371-8511,Japan
Tel
027-220-8740
hitotaisho-ciru@ml.gunma-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
医療法人真木会真木病院、群馬大学大学院保健学研究科
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 23 | Day |
Last modified on
| 2026 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071728
