- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02653807
Comparison of Two Manual Therapy Techniques on Ankle Dorsiflexion
The Immediate Effects of Two Manual Therapy Techniques on Ankle Musculoarticular Stiffness and Dorsiflexion Range of Motion in People With Chronic Ankle Rigidity: A Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Increased musculoarticular stiffness (MAS) of the talocrural joint is a frequently encountered problem, identified during evaluation of weight bearing ankle dorsiflexion (WBADF). Such stiffness may follow ankle injury such as ankle sprain. In such a situation, MAS could be increased and might leads to a lack of joint flexibility as well as decreased dorsiflexion range-of-motion (ROM), however asymmetric rigidity does not necessarily always follow ankle sprain. Nevertheless, MAS is an important and necessary component of normal stability of the talocrural joint and could help to prevent abnormal ankle joint movement and ankle sprains.
Measurement of MAS can be determined by a technique known as free-oscillation, which is a comprehensive measure of joint stiffness comprising the stiffness of the muscle-tendon unit, skin, ligaments and joint capsule, along with a number of other mechanical and neuromuscular factors. The assessment of MAS is important when evaluating muscular performance, injury prevention and gender differences in flexibility. For example, men, as well as older people, are known to present with greater MAS than women and young people.
MAS of the talocrural joint can be objectively measured using an electromechanical device that imparts a passive oscillatory dorsiflexion movement, but also by means of clinical tests such as toe-wall distance and angular goniometric measurement during the weight bearing lunge test. Electromechanical measurement of ankle MAS has been used in several previous studies of asymptomatic participants and in patients with fibromyalgia syndrome, and spasticity after a stroke.
In orthopaedic manual therapy, different methods have been proposed to treat MAS associated with loss of dorsiflexion ROM at the talocrural joint. These include single session of Mulligan's Mobilization with Movement (MWM), anteroposterior mobilization of the talus, high velocity thrust, and Osteopathic Mobilization (OM). These methods have been described in clinical practice manuals, with greater proportion of studies reporting on the effects of MWM in comparison to high velocity thrust for improving ankle dorsiflexion ROM in chronic ankle instability or to study MWM efficacy in isolation for subacute or recurrent ankle sprains and for chronic ankle instability. With the exception of one study the results are generally in favor of MWM.
Generally MWM is an increasingly popular form of manual therapy for musculoskeletal disorders, concerning the ankle MWM try to improve talocrural ROM. MWM is a combination of accessory joint glide of the talus combined with active ankle dorsiflexion movement. The patient performs active WBADF while the therapist simultaneously applies an anteroposterior glide of the talus with respective posteroanterior tibial glide with the aid of a manual therapy belt. OM is a purely passive anteroposterior mobilization of the talus with respect to tibia, performed in a non weight-bearing position. To date, there have been no studies comparing the effectiveness of each technique with respect to electromechanically determined ankle MAS or ankle joint ROM determined by the WBADF lunge test.
Therefore, the aim of the study was to investigate the relative efficacy of MWM and OM on MAS as the primary outcome measurement and joint ROM during the WBADF lunge test as the secondary outcome measurement. The hypothesis was that MWM would produce significantly greater reduction in MAS and increased ankle joint ROM when compared to OM.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Brussels, Belgium, 1200
- IREC/CARS - Tour Pasteur - Saint-Luc Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- male gender, aged between 18 to 40 years, with a chronic unilateral mobility deficit of the talocrural joint; i.e. subjective blocking sensation and/or feeling of ankle stiffness together with the presence of ankle region pain/tenderness, during active WBADF while squatting. Subjects were recruited with chronic unilateral mobility deficit of the talocrural joint, which could be following a previous history of ankle injury or without previous history of ankle injury.
Exclusion Criteria:
- a history of ankle joint surgery or injury to the foot, ankle, knee or hip in the previous one-year.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: mobilization with movement
MWM at the talocrural joint during active weight bearing ankle dorsiflexion with the belt
|
manual therapy intervention
|
|
Active Comparator: osteopathic mobilization
passive mobilization of the talo-crural joint
|
manual therapy intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Electromechanical device measurement of MAS (Lehmann device, 1989)
Time Frame: Change from baseline until discharge of treatment (same day, single session)
|
The electromechanical device used to quantify musculoarticular stiffness had been used in previous research studies and has ben shown to have high precision, reliability and accuracy.
An oscillating footplate produces passive ankle joint dorsiflexion with 5° amplitude sinusoidal rotary displacements.
Thirty trials of 10 different oscillation frequencies, varying from 3 to 12 Hz, were applied on each subject during each session.
See Detrembleur and Plaghki (2000) for more details of the process.
|
Change from baseline until discharge of treatment (same day, single session)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
WBAD lunge test
Time Frame: Change from baseline until discharge of treatment (same day, single session)
|
the weight bearing ankle dorsiflexion lunge test a common clinical test used to evaluate ankle dorsiflexion ROM (Powden et al., 2015) which has been shown to have moderate to excellent intra-rater reliability (ICC = 0,65-0,99) with a minimal detectable change of 1,9 cm and 4,7°.
A graduated tape measure was placed on the floor, perpendicular to the wall.
The investigator demonstrated the measurement procedure test to the subject providing standardized instructions.
The subject placed his symptomatic foot with the big toe aligned on the tape measure and performed ankle dorsiflexion until his knee touched the wall.
An iPhone was used to measure the degree of tibial inclination.
|
Change from baseline until discharge of treatment (same day, single session)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Hidalgo B, Pitance L, Hall T, Detrembleur C, Nielens H. Short-term effects of Mulligan mobilization with movement on pain, disability, and kinematic spinal movements in patients with nonspecific low back pain: a randomized placebo-controlled trial. J Manipulative Physiol Ther. 2015 Jul-Aug;38(6):365-74. doi: 10.1016/j.jmpt.2015.06.013. Epub 2015 Jul 26.
- Bennell KL, Talbot RC, Wajswelner H, Techovanich W, Kelly DH, Hall AJ. Intra-rater and inter-rater reliability of a weight-bearing lunge measure of ankle dorsiflexion. Aust J Physiother. 1998;44(3):175-180. doi: 10.1016/s0004-9514(14)60377-9.
- Vicenzino B, Branjerdporn M, Teys P, Jordan K. Initial changes in posterior talar glide and dorsiflexion of the ankle after mobilization with movement in individuals with recurrent ankle sprain. J Orthop Sports Phys Ther. 2006 Jul;36(7):464-71. doi: 10.2519/jospt.2006.2265.
- Bleyenheuft C, Detrembleur C, Deltombe T, Fomekong E, Lejeune TM. Quantitative assessment of anaesthetic nerve block and neurotomy in spastic equinus foot: a review of two cases. J Rehabil Med. 2008 Nov;40(10):879-81. doi: 10.2340/16501977-0263.
- Dierick F, Detrembleur C, Trintignac G, Masquelier E. Nature of passive musculoarticular stiffness increase of ankle in female subjects with fibromyalgia syndrome. Eur J Appl Physiol. 2011 Sep;111(9):2163-71. doi: 10.1007/s00421-011-1850-2. Epub 2011 Feb 6.
- Gilbreath JP, Gaven SL, Van Lunen L, Hoch MC. The effects of mobilization with movement on dorsiflexion range of motion, dynamic balance, and self-reported function in individuals with chronic ankle instability. Man Ther. 2014 Apr;19(2):152-7. doi: 10.1016/j.math.2013.10.001.
- Lehmann JF, Price R, deLateur BJ, Hinderer S, Traynor C. Spasticity: quantitative measurements as a basis for assessing effectiveness of therapeutic intervention. Arch Phys Med Rehabil. 1989 Jan;70(1):6-15.
- Marron-Gomez D, Rodriguez-Fernandez AL, Martin-Urrialde JA. The effect of two mobilization techniques on dorsiflexion in people with chronic ankle instability. Phys Ther Sport. 2015 Feb;16(1):10-5. doi: 10.1016/j.ptsp.2014.02.001. Epub 2014 Feb 14.
- Powden CJ, Hoch JM, Hoch MC. Reliability and minimal detectable change of the weight-bearing lunge test: A systematic review. Man Ther. 2015 Aug;20(4):524-32. doi: 10.1016/j.math.2015.01.004. Epub 2015 Jan 29.
- Suydam SM, Soulas EM, Elliott DM, Silbernagel KG, Buchanan TS, Cortes DH. Viscoelastic properties of healthy achilles tendon are independent of isometric plantar flexion strength and cross-sectional area. J Orthop Res. 2015 Jun;33(6):926-31. doi: 10.1002/jor.22878. Epub 2015 Apr 27.
- Ditroilo M, Watsford M, Murphy A, De Vito G. Assessing musculo-articular stiffness using free oscillations: theory, measurement and analysis. Sports Med. 2011 Dec 1;41(12):1019-32. doi: 10.2165/11591470-000000000-00000.
- Collins N, Teys P, Vicenzino B. The initial effects of a Mulligan's mobilization with movement technique on dorsiflexion and pain in subacute ankle sprains. Man Ther. 2004 May;9(2):77-82. doi: 10.1016/S1356-689X(03)00101-2.
- Teixeira LM, Pires T, Silva RD, de Resende MA. Immediate effect of a single anteroposterior talus mobilization on dorsiflexion range of motion in participants with orthopedic dysfunction of the ankle and foot. J Manipulative Physiol Ther. 2013 Jul-Aug;36(6):369-75. doi: 10.1016/j.jmpt.2013.06.003. Epub 2013 Jul 11.
- Cejudo A, Sainz de Baranda P, Ayala F, Santonja F. A simplified version of the weight-bearing ankle lunge test: description and test-retest reliability. Man Ther. 2014 Aug;19(4):355-9. doi: 10.1016/j.math.2014.03.008. Epub 2014 Apr 2.
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
- IREC/CARS-UCL-Hidalgo
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ankle Stiffness
-
University of DaytonActive, not recruitingAnkle StiffnessUnited States
-
Hasan Kalyoncu UniversityCompletedMobility Limitation | Stiffness of Right Ankle, Not Elsewhere Classified | Stiffness of Left Ankle, Not Elsewhere Classified | Tone Increased, MuscleTurkey
-
Chinese University of Hong KongNot yet recruitingArterial Stiffness
-
University of PrimorskaCompleted
-
Superior UniversityActive, not recruitingStiffness; SacroiliacPakistan
-
Riphah International UniversityCompleted
-
International Society for Vascular HealthCompleted
-
National Taiwan University HospitalUnknownMuscle StiffnessTaiwan
-
Second Affiliated Hospital, School of Medicine,...RecruitingAnkle Ligament Injury,Chronic Ankle Instability,Ankle ArthroscopyChina
-
Second Affiliated Hospital, School of Medicine,...Not yet recruitingChronic Ankle Instability | Ankle Ligament Injury | Ankle Arthroscopy
Clinical Trials on mobilization with movement
-
Eleuterio Atanasio Sánchez RomeroCompletedChronic Low-back PainSpain
-
Natália Maria Oliveira CampeloCompletedPathologic Processes | Musculoskeletal Diseases | Joint Disease | Osteoarthritis Hip
-
Federal University of Health Science of Porto AlegreCompletedRotator Cuff Injuries | Shoulder PainBrazil
-
Riphah International UniversityCompletedImpingement SyndromePakistan
-
University of South CarolinaCompleted
-
The Hong Kong Polytechnic UniversityActive, not recruiting
-
César Fernández-de-las-PeñasUniversity of SalamancaCompleted
-
Escola Superior de Tecnologia da Saúde do PortoCompleted
-
Universidad Rey Juan CarlosNot yet recruiting
-
Foundation University IslamabadRecruitingHypomobility | Colles FracturePakistan