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The Toe-spread-out Exercise in Patients With Hallux Valgus and Without the Deformity

Primary Purpose

Hallux Valgus

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
toe-spread-out exercise
Sponsored by
Poznan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hallux Valgus focused on measuring hallux valgus,, toe-spread-out exercise, abductor hallucis muscle, surface electromyography

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • for patients with hallux valgus (research group A and control group): "B", "C" or "D" score in the Manchester scale, hallux valgus angle above 15° • for healthy volunteers (research group B) "A" score in the Manchester scale, hallux valgus angle equal or lower than 15°

Exclusion Criteria:

  • for all groups: a serious injury or a history of lower limb surgery, presence of pain from a disc disease on the background of the disco-radicular conflict (based on the ENG study), neuropathy, myopathy, rheumatoid arthritis, psoriatic arthritis, connective tissue diseases, a history of strokes or other neurological diseases.

Sites / Locations

  • Poznan University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

groups with toe-spread-out exercise

control group

Arm Description

This arm included individuals with hallux valgus (research group A) and without deformation (research group B), who were patients of Department of Rehabilitation, Poznan University of Medical Sciences. They performed the toe-spread-out exercises for 14 days and were examined twice: before and after exercises. The examination of participants included a surface electromyography, electroneurography and goniometer tests to measure the range of motion in the hallux joints.

This arm included individuals with hallux valgus deformity from the control group which did not undergo any therapy of hallux. They were patients of Department of Rehabilitation as well. These participants were examined twice at an interval of 14 days in the same way as the patients from experimental arm.

Outcomes

Primary Outcome Measures

Evaluation of changes in amplitude of motor unit action potential (MUAP)
The amplitude of motor unit action potential (MUAP) recorded from the abductor hallucis muscle in three phases of exercise and measured in mV

Secondary Outcome Measures

Evaluation of changes in frequency pattern of abductor hallucis muscle activity
The frequency pattern of the MUAP recruitment of abductor hallucis muscle activity based on the following classification patterns presented by Buchthal et al. and by Stalberg and Falck: interference (IF), intermediate (IM), poor (P) and straight (S).

Full Information

First Posted
January 21, 2018
Last Updated
February 3, 2018
Sponsor
Poznan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03423498
Brief Title
The Toe-spread-out Exercise in Patients With Hallux Valgus and Without the Deformity
Official Title
The Possibility of the Activation of the Abductor Hallucis Muscle as a Result of the Toe-spread-out Exercise in Patients With Hallux Valgus and in People Without the Deformity: Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
October 20, 2015 (Actual)
Primary Completion Date
September 10, 2017 (Actual)
Study Completion Date
December 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Poznan University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The effectiveness of conservative treatment of hallux valgus deformity has not been sufficiently explored yet. The aim of this study was to assess the effect of the toe-spread-out exercise on the amplitude and frequency pattern in a surface electromyographic examination in patients with hallux valgus and in people without the deformity. An additional objective is the assessment of nerve conduction in an electroneurography and the assessment of range of motion in a clinical examination.
Detailed Description
The study design was based on an interventional model (clinical trial). The participants were assigned to two research groups (A - with diagnosis of hallux valgus and B- without the deformity) that received therapeutic intervention of the TSO exercise performed unilaterally. The unexercised feet could have caused a synergistic effect and falsified the results, thus the unexercised feet were excluded from the control group. Nevertheless, a small control group which did not undergo any hallux therapy was created to check if any changes in analysed parameters are actually related to the intervention. These control group patients were examined twice at an interval of 14 days. The hallux deformities were assessed on the basis of X-ray images taken in weight-bearing conditions, in a standing position in the anterior-posterior projection. On all X-rays the hallux valgus angles (HVA) and the first intermetatarsal angles (FIA) were designated and measured by one radiologist. Additionally, each patient with hallux valgus was assessed according to the Hallux Metatarsophalangeal-Interphalangeal scale (HMP-IP scale) developed by the AOFAS (American Orthopaedic Foot and Ankle Society). The effects of the exercises were assessed using a comparison of the outcomes of two examinations: before and after therapy (research group A and B). For this purpose, a surface electromyographic examination (sEMG) recorded from the abductor hallucis (AbdH) muscle was performed. The following parameters of electromyography were analysed in three phases of TSO exercise: amplitude and frequency pattern. Additionally, the motor fibres of the tibial nerve and the sensory fibres of the sural nerve function in electroneurographic examination (ENG) and range of motion of hallux using goniometer were assessed. The sEMG recorded from the AbdH muscle and the ENG were performed with the use of the KeyPoint System (Medtronic A/S, Skovlunde, Denmark) and appropriate to the type of neurophysiological studies and set of electrodes (surface electrodes, bipolar stimulating electrode, and grounding electrode). For the analysis of the bioelectrical activity of the AbdH the standard disposable Ag/AgCl surface electrodes with an active surface of 5mm2 were applied. The active electrode (cathode) was located on the belly muscle and the reference electrode (anode) was attached 3 cm distally from the active electrode. For the purpose of the sEMG examinations, the time base on 80ms/D and sensitivity of the recording of 0.5mV/D were set. 10kHz upper and 20Hz lower filters of the recorder amplifier were used. The sEMG recordings were performed during three phases of the TSO exercise. The following parameters were analysed: amplitude of motor unit action potential (MUAP) measured in mV, and the frequency pattern of the MUAP recruitment of AbdH muscle activity. The sEMG tests with maintaining each phase of the TSO exercise were performed three times in order to obtain more objective results. The first test was treated as a training trial. The other two were taken into account to assess the amplitude and the frequency pattern. Only the trial with the highest amplitude and the most interference pattern was analysed as the result of the most effective recruitment of the MUAPs. The minimal and maximal amplitude values were automatically measured by the KeyPoint System after the marking of the MUAP amplitude peaks. An 'on-line' evaluation of the frequency of the MUAP recruitment during a maximal muscle contraction was a subjective visual assessment made by one experienced neurophysiologist. It was based on the following classification patterns presented by Buchthal et al. and by Stalberg and Falck: interference, intermediate, poor, and straight. In the ENG the following parameters of the CMAP (compound muscle action potential) from the tibial nerve and of the SNAP (sensory nerve action potential) from the sural nerve were analysed: amplitude (measured from a negative inflection to the baseline in mV or in µV), latency (measured in ms) and conduction velocity (measured in m/s). During the ENG the time base on 5ms/D and sensitivity of the recordings on 2mV/D were set. 10Hz upper and 10kHz lower filters of the recorder amplifier were used. In order to record the compound muscle action potentials (CMAP) evoked from the AbdH muscle, the same location of surface electrodes as in the EMG was used. The electrical stimulation of the tibial nerve was applied in two points: below the medial malleolus and in the popliteal fossa. The ground electrode was located in the plantar part of the foot. Single rectangular stimuli with duration of 0.2ms were delivered via bipolar electrode at 1Hz frequency while their intensity ranged from 30mA to the value evoking the supramaximal CMAP. For recordings of SNAP from the sural nerve antidromic and repetitive electrical stimulation with an intensity of 20 mA was required. Recording electrodes were placed near the lateral malleolus while the stimulation point was 15 cm proximally at the external border of the Achilles tendon. A clinical examination with the use of a goniometer was performed in the supine position of the patient. The investigator measured the range of the motion of the plantar and dorsal flexion in the first metatarsophalangeal joint and plantar flexion in the hallux interphalangeal joint.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus
Keywords
hallux valgus,, toe-spread-out exercise, abductor hallucis muscle, surface electromyography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
groups with toe-spread-out exercise
Arm Type
Experimental
Arm Description
This arm included individuals with hallux valgus (research group A) and without deformation (research group B), who were patients of Department of Rehabilitation, Poznan University of Medical Sciences. They performed the toe-spread-out exercises for 14 days and were examined twice: before and after exercises. The examination of participants included a surface electromyography, electroneurography and goniometer tests to measure the range of motion in the hallux joints.
Arm Title
control group
Arm Type
No Intervention
Arm Description
This arm included individuals with hallux valgus deformity from the control group which did not undergo any therapy of hallux. They were patients of Department of Rehabilitation as well. These participants were examined twice at an interval of 14 days in the same way as the patients from experimental arm.
Intervention Type
Other
Intervention Name(s)
toe-spread-out exercise
Intervention Description
The therapeutic intervention lasted 14 days and focused on doing the TSO exercise. This exercise was performed unilaterally under the supervision of a qualified physiotherapist. The starting position of the TSO exercise was the sitting position with the knee joint and hip bent at 90 degrees. The exercise consisted of 3 consecutive phases: dorsiflexion of the toes keeping the metatarsal heads and the heel on the ground, moving the fifth toe down and in a lateral direction, moving the big toe down and abduction. The final position needs to be maintained for 5 seconds. The whole sequence was repeated 200 times a day.
Primary Outcome Measure Information:
Title
Evaluation of changes in amplitude of motor unit action potential (MUAP)
Description
The amplitude of motor unit action potential (MUAP) recorded from the abductor hallucis muscle in three phases of exercise and measured in mV
Time Frame
2 weeks (14 days)
Secondary Outcome Measure Information:
Title
Evaluation of changes in frequency pattern of abductor hallucis muscle activity
Description
The frequency pattern of the MUAP recruitment of abductor hallucis muscle activity based on the following classification patterns presented by Buchthal et al. and by Stalberg and Falck: interference (IF), intermediate (IM), poor (P) and straight (S).
Time Frame
2 weeks (14 days)
Other Pre-specified Outcome Measures:
Title
Evaluation of changes in amplitude of the CMAP (compound muscle action potential) from the tibial nerve and of the SNAP (sensory nerve action potential) from the sural nerve
Description
The amplitude measured from a negative inflection to the baseline in mV.
Time Frame
2 weeks (14 days)
Title
Evaluation of changes in latency of the CMAP (compound muscle action potential) from the tibial nerve and of the SNAP (sensory nerve action potential) from the sural nerve
Description
The latency measured in ms.
Time Frame
2 weeks (14 days)
Title
Evaluation of changes in conduction velocity of the CMAP (compound muscle action potential) from the tibial nerve and of the SNAP (sensory nerve action potential) from the sural nerve
Description
The conduction velocity measured in m/s.
Time Frame
Time frame: 2 weeks (14 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: for patients with hallux valgus (research group A and control group): "B", "C" or "D" score in the Manchester scale, hallux valgus angle above 15° • for healthy volunteers (research group B) "A" score in the Manchester scale, hallux valgus angle equal or lower than 15° Exclusion Criteria: for all groups: a serious injury or a history of lower limb surgery, presence of pain from a disc disease on the background of the disco-radicular conflict (based on the ENG study), neuropathy, myopathy, rheumatoid arthritis, psoriatic arthritis, connective tissue diseases, a history of strokes or other neurological diseases.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Przemysław Lisiński, MD, PhD
Organizational Affiliation
Poznan University of Medical Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kamila Mortka, Msc
Organizational Affiliation
Poznan University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Poznan University of Medical Sciences
City
Poznań
State/Province
Wielkopolska
ZIP/Postal Code
61-701
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
12704272
Citation
Arinci Incel N, Genc H, Erdem HR, Yorgancioglu ZR. Muscle imbalance in hallux valgus: an electromyographic study. Am J Phys Med Rehabil. 2003 May;82(5):345-9. doi: 10.1097/01.PHM.0000064718.24109.26.
Results Reference
background
PubMed Identifier
3383479
Citation
Hoffmeyer P, Cox JN, Blanc Y, Meyer JM, Taillard W. Muscle in hallux valgus. Clin Orthop Relat Res. 1988 Jul;(232):112-8.
Results Reference
background
PubMed Identifier
23640317
Citation
Kim MH, Kwon OY, Kim SH, Jung DY. Comparison of muscle activities of abductor hallucis and adductor hallucis between the short foot and toe-spread-out exercises in subjects with mild hallux valgus. J Back Musculoskelet Rehabil. 2013;26(2):163-8. doi: 10.3233/BMR-2012-00363.
Results Reference
background
PubMed Identifier
25995546
Citation
Kim MH, Yi CH, Weon JH, Cynn HS, Jung DY, Kwon OY. Effect of toe-spread-out exercise on hallux valgus angle and cross-sectional area of abductor hallucis muscle in subjects with hallux valgus. J Phys Ther Sci. 2015 Apr;27(4):1019-22. doi: 10.1589/jpts.27.1019. Epub 2015 Apr 30.
Results Reference
background
PubMed Identifier
13228110
Citation
BUCHTHAL F, PINELL P, ROSENFALCK P. Action potential parameters in normal human muscle and their physiological determinants. Acta Physiol Scand. 1954 Nov;32(2-3):219-29. doi: 10.1111/j.1748-1716.1954.tb01168.x. No abstract available.
Results Reference
background
PubMed Identifier
9546485
Citation
Stalberg E, Falck B. The role of electromyography in neurology. Electroencephalogr Clin Neurophysiol. 1997 Dec;103(6):579-98. doi: 10.1016/s0013-4694(97)00138-7.
Results Reference
background

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The Toe-spread-out Exercise in Patients With Hallux Valgus and Without the Deformity

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