UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062626 |
|---|---|
| Receipt number | R000060366 |
| Scientific Title | Effects of an Increased Steps Intervention on Shoulder Joint Function in Patients with Shoulder Rotator Cuff Repair |
| Date of disclosure of the study information | 2026/08/21 |
| Last modified on | 2026/08/19 21:55:13 |
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Basic information
Public title
Effects of an Increased Steps Intervention on Shoulder Joint Function in Patients with Shoulder Rotator Cuff Repair
Acronym
Effects of an Increased Steps Intervention on Shoulder Joint Function in Patients with Shoulder Rotator Cuff Repair
Scientific Title
Effects of an Increased Steps Intervention on Shoulder Joint Function in Patients with Shoulder Rotator Cuff Repair
Scientific Title:Acronym
Effects of Steps Intervention in Patients After Rotator Cuff Repair Surgery
Region
| Japan |
Condition
Condition
Patients with shoulder rotator cuff repair
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of a walking intervention up to 6 weeks postoperatively on shoulder pain and recovery of shoulder function in patients who have undergone arthroscopic rotator cuff repair
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Movement-related pain (NRS) at 6 weeks postoperative
Key secondary outcomes
Movement-related pain will be assessed at preoperative, 3-month postoperative, and 6-month postoperative time points. Resting pain and night pain will be assessed at preoperative, 6-week postoperative, 3-month postoperative, and 6-month postoperative time points. Pain will be assessed using the NRS scale.
Range of motion (flexion, abduction, and external rotation) and muscle strength (grip strength) will be assessed at preoperative, 6 weeks postoperative, 3 months postoperative, and 6 months postoperative time points, along with shoulder joint function (Shoulder Pain and Disability Index(SPADI), UCLA score, and Disabilities of the Arm, Shoulder, and Hand(DASH) score) and psychological assessment (Hospital Anxiety and Depression Scale(HADS) and Pain Self-Efficacy Questionnaire(PSEQ)).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
In addition to the regular rehabilitation program, patients perform walking exercises for at least 30 minutes per day, at least 4 times per week. The walking time may be continuous or broken up into shorter sessions. The walking program is to be continued from the date of discharge through 6 weeks post-surgery.
Interventions/Control_2
Only regular rehabilitation programs are performed. Patients are not given any instructions regarding walking.
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who underwent Arthroscopic rotator cuff repair
Patients whose postoperative rehabilitation program requires 4 weeks of brace immobilization
Patients who consented to this study
Key exclusion criteria
Patients indicated for rehabilitation programs that differ from the inclusion criteria
Patients with difficulty walking independently
Patients at high risk of falling
Patients who did not give consent for this study
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Seo |
Organization
Osaka Metropolitan University
Division name
Graduate School of Rehabilitation Science
Zip code
536-0025
Address
132-1 Morinomiya 2-chome, Joto-ku, Osaka-shi, Osaka, Japan
TEL
06-6167-1262
mitsuhiro_s_eo@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Seo |
Organization
Osaka Metropolitan University
Division name
Graduate School of Rehabilitation Science
Zip code
536-0025
Address
132-1 Morinomiya 2-chome, Joto-ku, Osaka-shi, Osaka, Japan
TEL
06-6167-1262
Homepage URL
mitsuhiro_s_eo@yahoo.co.jp
Sponsor or person
Institute
Osaka Metropolitan 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
Osaka Metropolitan University, Graduate School of Rehabilitation Science
Address
132-1 Morinomiya 2-chome, Joto-ku, Osaka-shi, Osaka, Japan
Tel
06-6167-1255
iwata@omu.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
運動器ケア しまだ病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 21 | 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
81
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2026 | 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
| 2026 | Year | 08 | Month | 19 | Day |
Last modified on
| 2026 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060366
