UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055210 |
|---|---|
| Receipt number | R000063082 |
| Scientific Title | Neuromuscular Electrical Stimulation on Hip Abductor Muscles After Total Hip Arthroplasty Pilot Study |
| Date of disclosure of the study information | 2024/09/01 |
| Last modified on | 2024/08/09 18:38:23 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Neuromuscular Electrical Stimulation on Hip Abductor Muscles After Total Hip Arthroplasty Pilot Study
Acronym
Neuromuscular Electrical Stimulation on Hip Abductor Muscles After Total Hip Arthroplasty Pilot Study
Scientific Title
Neuromuscular Electrical Stimulation on Hip Abductor Muscles After Total Hip Arthroplasty Pilot Study
Scientific Title:Acronym
Neuromuscular Electrical Stimulation on Hip Abductor Muscles After Total Hip Arthroplasty Pilot Study
Region
| Japan |
Condition
Condition
After Total Hip Arthroplasty
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to examine whether strength training using NMES (neuromuscular electrical stimulation) on the hip abductor muscles of patients after THA (total hip arthroplasty) could be safely conducted and whether the intervention was feasible. This study is a pilot study conducted as a preliminary step before a randomized controlled trial (RCT), with the objective of calculating the effect size necessary to determine the sample size required for the RCT.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximum isometric hip abductor strength
At the start of the intervention and at the end of the 8-week intervention
Key secondary outcomes
Trendelenburg Test
Timed Up Go Test
Chair Standing 30 Second
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
In addition to the standard 40-minute rehabilitation, neuromuscular electrical stimulation (NMES) will be applied to the hip abductor muscles on the surgical side for 20 minutes (10 minutes of stepping exercises and 10 minutes of hip abduction exercises). The intervention period will consist of two sessions per week for eight weeks.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The underlying condition is osteoarthritis of the hip, and the study will include patients who have undergone their first total hip arthroplasty (THA). Among these, only those who can attend outpatient rehabilitation at our hospital at least twice a week will be included.
Key exclusion criteria
The study will exclude individuals who find it difficult to attend outpatient rehabilitation twice a week, those with rheumatoid arthritis, revision surgery, a history of lower limb joint surgery, severe heart disease, neurological disorders, dementia, or those who are unable to maintain a standing position for 10 minutes.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Yagi |
Organization
Sonodakai Joint Replacement Center
Division name
Rehabilitation
Zip code
121-0064
Address
Toukyouto Adatiku Hokima1-21-10
TEL
0358311811
yagiyagi08037777@gmail.com
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Yagi |
Organization
Sonodakai Joint Replacement Center
Division name
Rehabilitation
Zip code
121-0064
Address
Toukyouto Adatiku Hokima1-21-10
TEL
0358311811
Homepage URL
yagiyagi08037777@gmail.com
Sponsor or person
Institute
Sonodakai Joint Replacement Center
Institute
Department
Personal name
Funding Source
Organization
Sonodakai Joint Replacement Center
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
Sonodakai Joint Replacement Center
Address
Toukyouto Adatiku Hokima1-21-10
Tel
0358311811
yagiyagi08037777@gmail.com
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2024 | Year | 08 | Month | 09 | Day |
Last modified on
| 2024 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063082
