UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054354 |
|---|---|
| Receipt number | R000062004 |
| Scientific Title | Effects of fixed limb position during orthosis therapy on joint range of motion and muscle activity in thumb CM arthropathy |
| Date of disclosure of the study information | 2024/05/09 |
| Last modified on | 2025/02/03 11:47:00 |
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Basic information
Public title
Effects of orthotic therapy on upper limb function in thumb arthropathy
Acronym
Research on the effects of orthotic therapy on orthopedic disorders
Scientific Title
Effects of fixed limb position during orthosis therapy on joint range of motion and muscle activity in thumb CM arthropathy
Scientific Title:Acronym
Verification of the intervention effect of fixed limb position during orthosis therapy on joint range of motion and muscle activity in patients with carpometacarpal(CMC) arthropathy:randomized controlled trial
Region
| Japan |
Condition
Condition
Thumb CM arthropathy
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to create two types of splints, one fixed in radial abduction and one fixed in palmar abduction, for patients with thumb CM arthropathy, and to clarify the effects of fixed limb position on joint range of motion and muscle activity. Clarifying the effects of different fixed limb positions on joint range of motion and muscle activity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Range of motion(ROM) in preoperative and postoperative evaluations (automatic or passive range of motion of thumb radial abduction, ulnar adduction, palmar abduction, palmar adduction, metacarpophalangeal(MP) joint flexion/extension, interphalangeal(IP) joint flexion/extension) difference
Key secondary outcomes
Preoperatively and postoperatively
(a) Differences in muscle strength such as pinch strength (finger pads/flanks) and grip strength
(b) Differences in thumb opposition function based on kapandji score
(c) Difference in pain based on Visual Analogue Scale(VAS) (rest, exercise, and weight bearing)
(d) Comparison of functional evaluation of hand pathology using Michigan Hand Outcomes Questionnaire(MHQ)
(e) Differences in upper limb function based on Simple Test for Evaluating Hand Function(STEF) and modified STEF
(f) Comparison of muscle activity using surface electromyogram (integral value of thenar muscle)
(g) Comparison of muscle contraction during exercise using ultrasound examination (muscle thickness of thenar muscle)
(h)Mini Mental State Examination
(i)Purdue Pegboard Test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
radial abduction group
During the 3-week postoperative immobilization period, the limb was immobilized using a splint for the first postoperative week, and the limb was placed in radial abduction position using a splint during the first postoperative week.
Interventions/Control_2
palmar abduction group
During the 3-week postoperative immobilization period, the limb was immobilized using a splint for the first postoperative week, and the limb was placed in palmar abduction position using a splint during the first postoperative week.
Interventions/Control_3
Conservative treatment group
Surgery is not performed, and treatment includes exercise and orthotic therapy.
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
Female
Key inclusion criteria
(a) Patients who are at least 18 years of age (adult) at the time of enrollment and have no cognitive impairment that would preclude their consent to participate in the study.
(b) Female patients diagnosed with CM arthropathy of the thumb and scheduled for conservative treatment and surgery (plasty).
Key exclusion criteria
Patients with neurological symptoms such as complex regional pain syndrome, patients with a history of surgery on the thumb, and patients who have undergone procedures or surgery that may affect postoperative ROM such as joint fusion surgery.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Irie |
Organization
Kyoto University
Division name
Department of Clinical Cognitive Neuroscience, Department of Human Health Sciences, Graduate School of Medicine
Zip code
606-8507
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3968
irie.keisuke.8n@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Irie |
Organization
Kyoto University
Division name
Department of Clinical Cognitive Neuroscience, Department of Human Health Sciences, Graduate School
Zip code
606-8507
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3968
Homepage URL
irie.keisuke.8n@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School of Medicine/Faculty of Medicine and Faculty of Medicine Hospital Medical Ethics Committee
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto 606-8507
Tel
075-753-4680
ethcom@kuhp.kyoto-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
十条武田リハビリテーション病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 09 | 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 | 03 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2026 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2026 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2026 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 09 | Day |
Last modified on
| 2025 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062004
