UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047296 |
|---|---|
| Receipt number | R000052476 |
| Scientific Title | Effects of isometric ankle plantar flexion contraction exercises with visual and auditory feedback on pain, motor function, and quality of life in patients with foot or ankle fractures |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2024/02/20 19:06:37 |
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Basic information
Public title
Effects of ankle joint exercises with visual and auditory feedback on pain, motor function, and quality of life in patients with ankle or foot fractures
Acronym
Effects of ankle joint exercises with using visual and auditory feedback
Scientific Title
Effects of isometric ankle plantar flexion contraction exercises with visual and auditory feedback on pain, motor function, and quality of life in patients with foot or ankle fractures
Scientific Title:Acronym
Effects of isometric exercise with visual and auditory feedback on patients with foot and ankle fractures
Region
| Japan |
Condition
Condition
Foot or ankle fractures
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of exercise with visual and auditory feedback on pain, physical performance, and QOL in postoperative patients with foot and ankle fractures.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Visual Analogue Scale
Key secondary outcomes
Postoperatively, the following evaluations will be performed at the start of loading and 4 weeks after the start of loading.
Short-Form McGill Pain Questionnaire
Pain Catastrophizing Scale
Hospital Anxiety and Depression Scale
Neglect Like Symptom Score
Tampa Scale for kinesiophobia
pressure pain threshold
Two-point identification
Range of motion
Muscle strength
10m walking time
Walking distance for six minutes
self-administered foot evaluation
questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention group: After surgery, isometric ankle plantar flexion exercise using visual and auditory feedback is performed in addition to normal rehabilitation from the start of loading to 4 weeks after the start of loading. Isometric ankle plantar flexion exercises using visual and auditory feedback are performed 5 times a week, 10 times for 10 seconds, 3 sets.
Interventions/Control_2
Control group: Only normal rehabilitation is performed after surgery and after the start of loading.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with foot and ankle joint fractures underwent surgery
Key exclusion criteria
Those with serious arrhythmia
Those with a tendency to bleed
Those with obvious inflammatory symptoms (redness, heat, swelling, too much pain)
Have malignant tumor
If there is sensory disturbance
If there is infection
Unstable circulatory dynamics
Peripheral circulatory disturbance
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Kataoka |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Physical Therapy Science
Zip code
852-8520
Address
1-7-1 Sakamoto Nagasaki Japan
TEL
0958197967
kataoka-hide@kii.bbiq.jp
Public contact
Name of contact person
| 1st name | HIDEKI |
| Middle name | |
| Last name | KATAOKA |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Physical Therapy Science
Zip code
852-8520
Address
1-7-1 Sakamoto Nagasaki Japan
TEL
0958197967
Homepage URL
kataoka-hide@kii.bbiq.jp
Sponsor or person
Institute
Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University Graduate School of Biomedical Sciences
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
Graduate School of Biomedical Sciences, Health Science Courses, Ethics Committee.
Address
12-4 Sakamoto Nagasaki Japan
Tel
0958197198
miyaji195@nagasaki-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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | 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
| 2021 | Year | 11 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 03 | 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
| 2022 | Year | 03 | Month | 27 | Day |
Last modified on
| 2024 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052476
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