UMIN-ICDS Clinical Trial

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

After anterior cruciate ligament reconstruction

Classification by specialty

Orthopedics

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

Email

smsb482912@gmail.com

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

Email

smsb482912@gmail.com

Institute

Seikeikai chiba medical center

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Seikeikai chiba medical center

Address

1-7-1 Minamicho Chuo-ku Chiba-shi Chiba Japan

Tel

0432615111

Email

smsb482912@gmail.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2024

Year

01

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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/icdr_e/ctr_view.cgi?recptno=R000060447