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

NCT03423498 | Completed

• 1 other identifier: 886/15
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Hallux Valgus

Keywords

hallux valgus,; toe-spread-out exercise; abductor hallucis muscle; surface electromyography

Outcome Measures

Primary Outcomes (1)

• 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

  2 weeks (14 days)

Secondary Outcomes (1)

• Evaluation of changes in frequency pattern of abductor hallucis muscle activity

  2 weeks (14 days)

Other Outcomes (3)

• 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

  2 weeks (14 days)

• 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

  2 weeks (14 days)

• 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

  Time frame: 2 weeks (14 days)

Study Arms (2)

groups with toe-spread-out exercise

EXPERIMENTAL

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.

Other: toe-spread-out exercise

control group

NO INTERVENTION

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.

Interventions

toe-spread-out exercise OTHER

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.

groups with toe-spread-out exercise

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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°

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Poznan University of Medical Sciences

Poznan, Wielkopolska, 61-701, Poland

Location

Related Publications (6)

• 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.

  PMID: 12704272 BACKGROUND

• Hoffmeyer P, Cox JN, Blanc Y, Meyer JM, Taillard W. Muscle in hallux valgus. Clin Orthop Relat Res. 1988 Jul;(232):112-8.

  PMID: 3383479 BACKGROUND

• 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.

  PMID: 23640317 BACKGROUND

• 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.

  PMID: 25995546 BACKGROUND

• 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.

  PMID: 13228110 BACKGROUND

• 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.

  PMID: 9546485 BACKGROUND

MeSH Terms

Conditions

Hallux Valgus

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Study Officials

• Przemysław Lisiński, MD, PhD

  Poznan University of Medical Sciences

  STUDY DIRECTOR

• Kamila Mortka, Msc

  Poznan University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant, MSc

Study Record Dates

• First Submitted: January 21, 2018
• First Posted: February 6, 2018
• Study Start: October 20, 2015
• Primary Completion: September 10, 2017
• Study Completion: December 20, 2017
• Last Updated: February 6, 2018

Record last verified: 2018-02

Locations

PL (1)