UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052998 |
|---|---|
| Receipt number | R000060447 |
| Scientific Title | The effect of short foot exercise with exercise therapy on lower-limb motor control after anterior cruciate ligament reconstruction |
| Date of disclosure of the study information | 2024/01/07 |
| Last modified on | 2023/12/04 19:56:18 |
* 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
The effect of short foot exercise with exercise therapy on lower-limb motor control after anterior cruciate ligament reconstruction
Acronym
The effect of short foot exercise after anterior cruciate ligament reconstruction
Scientific Title
The effect of short foot exercise with exercise therapy on lower-limb motor control after anterior cruciate ligament reconstruction
Scientific Title:Acronym
The effect of short foot exercise with exercise therapy after anterior cruciate ligament reconstruction
Region
| Japan |
Condition
Condition
After anterior cruciate ligament reconstruction
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Anterior cruciate ligament tear is a common injury during sports activities. Anterior cruciate ligament reconstruction (ACLR) is a major operation for injured people to return to sports activities (Thaunat et al. 2019). The most important purpose of physiotherapy after ACLR is to prevent re-injury. Lower-limb motor control function during landing has a crucial role in achieving the purpose. The foot has multiple functions, such as absorbing shock and providing sensory input from the ground. It is also important in lower-limb motor control after ACLR (Carson et al. 2016). In particular, intrinsic foot muscles (IFMs) have important roles in lower-limb motor control because they form the arch structures of a foot and have the function of sensory receptors (McKeon et al. 2015). Short foot exercise (SFE) and Toe curl exercise (TC) are the exercises for IFMs. The purpose of this study is to clarify the effect of SFE with exercise therapy on lower-limb motor control after ACLR.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Single-leg landing: Participants perform single-leg landing from the 30cm step and maintain the landing position for 3 seconds. The measurement is performed 3 times. Two smartphones (iPhone SE, Apple) on the tripod are set at 5m distance and 35 degree wide from the landing point. The trials are recorded at 240fps according to the protocol of the markerless motion capture system (OpenCap, Stanford University). The data will be analyzed by the motion analysis software (OpenSim, National Center for Simulation in Rehabilitation Research). The maximum knee valgus, hip adduction, and planter flexion are analyzed after filtering with a cut-off frequency of 15 Hz.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The short foot exercise participants flex metatarsophalangeal joints toward the heel without flexing interphalangeal joints. The exercises are performed once per day for 12 weeks with a 5-s hold and 5-s rest for 5 minutes. In the first four weeks, the participants perform the exercises while sitting. In the next four weeks, they perform it while standing, followed by single-leg standing for the last four weeks. The instruction is provided once per week using electromyography (TS-MYO, TRUNK SOLUTION) and ultrasound (iU22, PHILIPS). Exercise therapies are provided to both groups once per week. SFE participants perform exercise therapy with the queuing for the foot.
Interventions/Control_2
The toe curl exercise participants flex all toes with maximum power. The exercises are performed once per day for 12 weeks with a 5-s hold and 5-s rest for 5 minutes. In the first four weeks, the participants perform the exercises while sitting. In the next four weeks, they perform it while standing, followed by single-leg standing for the last four weeks. The instruction is provided once per week using electromyography (TS-MYO, TRUNK SOLUTION) and ultrasound (iU22, PHILIPS). Exercise therapies are provided to both groups once per week.TC participants perform it without queuing for the foot.
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
| 16 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
a) BMI more than 18.5, less than 25.0, b)Tegner activity score is more than 5, c)Post operation time is more than six months, d)The tibial tuberosity crossed the vertical line on the 2nd toe during single-leg landing from 30cm steps.
Key exclusion criteria
a) Revision ACLR, b) Sever concomitant procedure (Medial collateral ligament, Meniscus suture with more than ten stitches), c) Participants with pain in static condition and during movements.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Misaki |
| Middle name | |
| Last name | Suzuki |
Organization
Seikei-kai Chiba medical center, Tokyo Metropolitan University
Division name
Department of rehabilitation
Zip code
2600842
Address
1-7-1 Minamicho Chuo-ku Chiba-shi Chiba Japan
TEL
0432615111
smsb482912@gmail.com
Public contact
Name of contact person
| 1st name | Misaki |
| Middle name | |
| Last name | Suzuki |
Organization
Seikeikai chiba medical center
Division name
Department of rehabilitation
Zip code
2600842
Address
1-7-1 Minamicho Chuo-ku Chiba-shi Chiba Japan
TEL
0432615111
Homepage URL
smsb482912@gmail.com
Sponsor or person
Institute
Seikeikai chiba medical center
Institute
Department
Personal name
Funding Source
Organization
None
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
Seikeikai chiba medical center
Address
1-7-1 Minamicho Chuo-ku Chiba-shi Chiba Japan
Tel
0432615111
smsb482912@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 | 01 | Month | 07 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 01 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 07 | 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
| 2023 | Year | 12 | Month | 04 | Day |
Last modified on
| 2023 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060447
