- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01082432
Electrical Stimulation to Recover Greater Range of Motion After Surgery
Superimposed Electrical Stimulation Real-time Effects on Repeated Muscle Contractions Enable to Increase Recovery From Thumb Joint Stiffness After Surgery of the Ulnar Collateral Ligament
Background
One of the potentially debilitative complications of operative repair and subsequent immobilization is stiffness that appears secondary to inflammation and adhesions. To prevent such a physical impairment, active joint mobilization has shown to be efficient. However, adhesions sometimes remain despite the therapy. Due to the viscoelastic nature of the biological tissues, if a technique can enable to extend the muscle ability to impose a maximal steady stress on adhesions, adhesion deformation should be greater and range of motion deficit should be reduced. Within that context, the purpose of the present study was to assess the real-time effects of superimposed electrical stimulation (SES) on maximal voluntary muscular contraction (VOL) over time and to assess SES effects on range of motion recovery in thumb stiff joint.
Methods and Findings
The aim of the first experiment was to examine the real-time effects of tetanic SES on the maximal volitional level of force over repeated contractions of the triceps brachii muscle. To address this goal, seventeen subjects participated voluntarily in this study. Two features of the muscular force were assessed: The peak force (1) and the impulse (2). These two dependent variables were measured during 500 sec - including 50 maximal force productions of 4 sec each- in two randomized conditions of VOL and SES. When considering the 50 trials as a whole, exerted force was higher in the SES than in the VOL condition for both peak force and impulse (P<.05). Over time, peak force and impulse decreased consistently in VOL starting between the 20th and 30th trials whereas they were maintained in SES condition (P<.05).
The aim of the second experiment was to compare the effects of VOL and SES on the range of flexion recovery of the stiff metacarpophalangeal joint following operative repair of the ulnar collateral ligament of the thumb. To address this goal, eight patients participated voluntarily. Range of motion, oedema and pain were assessed before and after the two randomised conditions of VOL and SES.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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La Tronche, France, 38700
- Université Joseph Fourier - TIMC IMAG laboratory
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- loss of range of flexion in the involved metacarpophalangeal joint of at least ten degrees when compared to the opposite thumb
- more than eight weeks post-surgery
Exclusion Criteria:
- do not meet the inclusion criteria
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
range of motion
Time Frame: 1sec after joint mobilization
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Active range of motion was measured using a finger goniometer
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1sec after joint mobilization
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
muscle force
Time Frame: During the muscle contraction
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The peak force and the impulse were measured during 500 sec in two randomized conditions of voluntary muscle contraction and electrically induced muscle contraction
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During the muscle contraction
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Vincent Nougier, PhD, Université Joseph Fourier - TIMC IMAG laboratory
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SES 327
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