UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052726 |
|---|---|
| Receipt number | R000060160 |
| Scientific Title | The Effect of Massage on the Plantar flexor muscles during The Fixation period in Postoperative patients with an Ankle fracture |
| Date of disclosure of the study information | 2023/11/08 |
| Last modified on | 2024/05/08 10:06:06 |
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Basic information
Public title
The Effect of Massage on the Plantar flexor muscles during The Fixation period in Postoperative patients with an Ankle fracture
Acronym
The Effect of Massage on the Plantar flexor muscles during The Fixation period in Postoperative patients with an Ankle fracture
Scientific Title
The Effect of Massage on the Plantar flexor muscles during The Fixation period in Postoperative patients with an Ankle fracture
Scientific Title:Acronym
The Effect of Massage on the Plantar flexor muscles during The Fixation period in Postoperative patients with an Ankle fracture
Region
| Japan |
Condition
Condition
Patient with ankle fracture
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Ankle fractures are one of the most common lower extremity fractures. After surgery, the ankle joint is often immobilized in a plantar flexion position, and there have been many reported cases of limited ankle joint range of motion. Therefore, the purpose of the present study was to investigate the effect of regular massage interventions on ankle joint range of motion after removal of fixation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary objective of the present study was to investigate whether 3-minute massage interventions on the plantar flexors during cast fixation in postoperative ankle joint patients could improve ankle joint ROM after fixation removal.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
In addition to regular physical therapy, the physical therapist administered a 3-minute massage to the plantar flexors at the cast- or splint-exposed areas. These three-minute massage interventions were performed twice a day, five times a week.
Interventions/Control_2
Patients with ankle fractures who received regular physical therapy
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
| 20 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with ankle fractures who suffered an ankle fracture and were admitted to our hospital for surgical fixation
Key exclusion criteria
The exclusion criteria were as follows: those who would not provide consent to participating in the study; those who had severe motor paralysis due to stroke; and those who had ankle joint fixation for less than 7 days after surgery.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masanobu |
| Middle name | |
| Last name | Yokochi |
Organization
Takeda General Hospital
Division name
Department of Rehabilitation
Zip code
965-8585
Address
3-27 Yamagamachi, Aizuwakamatsu, Fukushima
TEL
0242275511
masanobu815@hotmail.com
Public contact
Name of contact person
| 1st name | Masanobu |
| Middle name | |
| Last name | Yokochi |
Organization
Takeda General Hospital
Division name
Department of Rehabilitation
Zip code
965-8585
Address
3-27 Yamagamachi, Aizuwakamatsu, Fukushima
TEL
0242275511
Homepage URL
masanobu815@hotmail.com
Sponsor or person
Institute
Takeda General Hospital
Institute
Department
Personal name
Masanobu Yokochi
Funding Source
Organization
Takeda General Hospital
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Takeda General Hospital
Address
3-27 Yamagamachi, Aizuwakamatsu, Fukushima
Tel
0242275511
masanobu815@hotmail.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
| 2023 | Year | 11 | Month | 08 | Day |
Related information
URL releasing protocol
https://www.bodyworkmovementtherapies.com/
Publication of results
Published
Result
URL related to results and publications
https://www.bodyworkmovementtherapies.com/
Number of participants that the trial has enrolled
30
Results
Our results indicate that regular 3-min massage interventions of the plantar flexors could prevent the
progression of a range of motion limitations in postoperative patients with an ankle fracture more effectively
than regular physical therapy alone
Results date posted
| 2024 | Year | 05 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
postoperative patients with an ankle fracture
Participant flow
postoperative patients with an ankle fracture
Adverse events
None
Outcome measures
Ankle Joint Range of Motion
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2022 | 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
| 2023 | Year | 11 | Month | 07 | Day |
Last modified on
| 2024 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060160
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