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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03423498
Date of registration: 21/01/2018
Prospective Registration: No
Primary sponsor: Poznan University of Medical Sciences
Public title: The Toe-spread-out Exercise in Patients With Hallux Valgus and Without the Deformity
Scientific 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.
Date of first enrolment: October 20, 2015
Target sample size: 51
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03423498
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).  
Phase:  N/A
Countries of recruitment
Poland
Contacts
Name:     Kamila Mortka, Msc
Address: 
Telephone:
Email:
Affiliation:  Poznan University of Medical Sciences
Name:     Przemyslaw Lisinski, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Poznan University of Medical Sciences
Key inclusion & exclusion 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.



Age minimum: 20 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Hallux Valgus
Intervention(s)
Other: toe-spread-out exercise
Primary Outcome(s)
Evaluation of changes in amplitude of motor unit action potential (MUAP) [Time Frame: 2 weeks (14 days)]
Secondary Outcome(s)
Evaluation of changes in frequency pattern of abductor hallucis muscle activity [Time Frame: 2 weeks (14 days)]
Secondary ID(s)
886/15
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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