- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05405023
Effects of Concentric Exercise With and Without Mulligan Wrist Mobilization After Distal Radius Fracture.
Effects of Concentric Exercise With and Without Mulligan Wrist Mobilization on Pain, Grip Strength, Range of Motion and Function After Distal Radius Fracture.
The distal end of the radius is defined as the area three centimeters proximal to the radio carpal joint, where the radius interfaces with the lunate and scaphoid bone of the wrist. A fracture of the distal radius is usually caused by falling on the outstretched arm. The majority of distal radial fractures are closed injuries in which the overlying skin remains intact. Pain, swelling, bruising, deformity and deformity in the forearm or wrist are common. In women, the incidence of distal radial fracture increases with age from 40 years. The objective of this study will be to determine the Effects of Concentric exercises with and without mulligan wrist mobilization on pain, grip strength, Range of motion and function after distal radius fracture.
This study will be a randomized controlled trial and will be conducted in District Head Quarter hospital sheikhupura. The study will be completed in time duration of six months after the approval of synopsis and convenience sampling technique will be used. 18 subjects will be divided in two groups. Group A will follow concentric exercises at wrist including flexion, extension, abduction, adduction, pronation, supination and wrist mobilizations with movements while group B will follow only wrist concentric exercises treatment. MWM based on Mulligan's Recommendation that the patient should not experience any pain. The Location and direction of the glide could be modified so that the MWM was pain free, as advocated in the Mulligan concept. This study will be of 4 weeks, 3 sessions per week. Data will be collected by all participants before 1st session after 6th session and at the end of 12th session by using NPRS, Hand Dynamometer, Goniometer and Patient Rated Wrist Evaluation score. Data will be analyzed by SPSS-25.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Sheikhupura, Punjab, Pakistan, 39350
- DHQ Hospital Sheikhupura
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Contact:
- Saba Rafique, Phd*
- Phone Number: +923034045433
- Email: saba.rafique@riphah.edu.pk
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Principal Investigator:
- Iqra Shahzadi, MsPT (OMPT)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age: 35-70 years
- Subjects with at least 6 weeks of distal radius fracture
- Orthopedic surgeon advise
Exclusion Criteria:
- Neurological problem affecting upper limb
- Parkinson disease
- Subjects having polyarthritis, bleeding disorders, tumors, local infection, peripheral vascular disease
- Any contraindication to physiotherapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Concentric exercises with wrist mobilization
concentric exercise including wrist flexion, extension, and abduction, adduction, supination and pronation plus wrist mobilizations with movements
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Participants will receive concentric exercise including wrist flexion, extension, and abduction, adduction, supination and pronation plus wrist mobilizations with movements.
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ACTIVE_COMPARATOR: Concentric exercises without wrist mobilization
concentric exercise including wrist flexion, extension, and abduction, adduction, supination and pronation
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Participants will receive concentric exercises only.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wrist Pain
Time Frame: 4 weeks
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NPRS is anchored by terms describing pain severity extremes.
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g.
"no pain") to '10' representing the other pain extreme (e.g.
"pain as bad as you can imagine" or "worst pain imaginable").
|
4 weeks
|
|
Grip Strength
Time Frame: 4 weeks
|
Handheld dynamometers are used for measuring grip strength.
They are available in manual and digital version so there is a need to know the reliability of manual hand-held dynamometer and digital hand-held for measuring grip strength.
Excellent reliability is found for manual and digital handheld dynamometers
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4 weeks
|
|
Range of motion
Time Frame: 4 weeks
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Goniometer is used to measure Range of motion.
Hand-held pencil (HHP) and the plumb line goniometer (PLG) methods are used for measuring active forearm pronation and supination motions in individuals with and without injuries.
The HHP and PLG are highly reliable methods for measuring functional forearm pronation and supination.
Because plumb line goniometers are not commercially available and the instrumentation for the HHP method is readily accessible, clinicians should consider the latter as their method of choice for measuring functional forearm pronation and supination
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4 weeks
|
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Wrist Function
Time Frame: 4 weeks
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For evaluating function Patient Rated Wrist Evaluation (PRWE) score is used.
High-quality evidence supports the use of PRWE/PRWHE as a reliable, valid, and structurally sound questionnaire to assess pain and disability in patients with various wrist and hand injuries.
The PRWE/PRWHE has been translated into 21 languages.
High-quality evidence supports very good structural and cross-cultural validity, internal consistency, test-retest reliability, measurement error, and hypothesis testing for construct validity against DASH in wrist and hand injuries.
However, low-quality evidence supports acceptable responsiveness property
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4 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Saba Rafique, Phd*, Riphah International University
Publications and helpful links
General Publications
- Meena S, Sharma P, Sambharia AK, Dawar A. Fractures of distal radius: an overview. J Family Med Prim Care. 2014 Oct-Dec;3(4):325-32. doi: 10.4103/2249-4863.148101.
- Quadlbauer S, Pezzei C, Jurkowitsch J, Rosenauer R, Kolmayr B, Keuchel T, Simon D, Beer T, Hausner T, Leixnering M. Rehabilitation after distal radius fractures: is there a need for immobilization and physiotherapy? Arch Orthop Trauma Surg. 2020 May;140(5):651-663. doi: 10.1007/s00402-020-03367-w. Epub 2020 Mar 19.
- Gutierrez-Espinoza H, Rubio-Oyarzun D, Olguin-Huerta C, Gutierrez-Monclus R, Pinto-Concha S, Gana-Hervias G. Supervised physical therapy vs home exercise program for patients with distal radius fracture: A single-blind randomized clinical study. J Hand Ther. 2017 Jul-Sep;30(3):242-252. doi: 10.1016/j.jht.2017.02.001. Epub 2017 Mar 22.
- Gutierrez-Espinoza H, Araya-Quintanilla F, Olguin-Huerta C, Valenzuela-Fuenzalida J, Gutierrez-Monclus R, Moncada-Ramirez V. Effectiveness of manual therapy in patients with distal radius fracture: a systematic review and meta-analysis. J Man Manip Ther. 2022 Feb;30(1):33-45. doi: 10.1080/10669817.2021.1992090. Epub 2021 Oct 20.
- Coughlin T, Norrish AR, Scammell BE, Matthews PA, Nightingale J, Ollivere BJ. Infographic: Comparison of rehabilitation interventions in nonoperatively treated distal radius fractures: a randomized controlled trial of effectiveness. Bone Joint J. 2021 Jun;103-B(6):1031-1032. doi: 10.1302/0301-620X.103B6.BJJ-2021-0729. No abstract available.
- Gutierrez-Espinoza H, Araya-Quintanilla F, Olguin-Huerta C, Gutierrez-Monclus R, Jorquera-Aguilera R, Mathoulin C. Effectiveness of early versus delayed motion in patients with distal radius fracture treated with volar locking plate: A systematic review and meta-analysis. Hand Surg Rehabil. 2021 Feb;40(1):6-16. doi: 10.1016/j.hansur.2020.10.007. Epub 2020 Nov 2.
- Tomruk M, Gelecek N, Basci O, Ozkan MH. Effects of early manual therapy on functional outcomes after volar plating of distal radius fractures: A randomized controlled trial. Hand Surg Rehabil. 2020 May;39(3):178-185. doi: 10.1016/j.hansur.2019.12.002. Epub 2020 Feb 15.
- Reid SA, Andersen JM, Vicenzino B. Adding mobilisation with movement to exercise and advice hastens the improvement in range, pain and function after non-operative cast immobilisation for distal radius fracture: a multicentre, randomised trial. J Physiother. 2020 Apr;66(2):105-112. doi: 10.1016/j.jphys.2020.03.010. Epub 2020 Apr 11.
- Aguilera-Godoy A, Antunez-Riveros MA, Carrasco-Penna G, Nunez-Cortes R. A post-surgical rehabilitation program for women over 60 years old who underwent surgery in trauma and orthopedic hospital after distal radius fracture. J Bodyw Mov Ther. 2021 Oct;28:362-368. doi: 10.1016/j.jbmt.2021.07.042. Epub 2021 Aug 10.
- Stathopoulos N, Dimitriadis Z, Koumantakis GA. Erratum to "Effectiveness of Mulligan's mobilization with movement techniques on pain and disability of peripheral joints: a systematic review with meta-analysis between 2008-2017" [Physiotherapy 105 (March (1)) (2019) 1-9]. Physiotherapy. 2020 Mar;106:219. doi: 10.1016/j.physio.2019.04.002. Epub 2019 Aug 30. No abstract available.
- Shafiee E, MacDermid J, Farzad M, Karbalaei M. A systematic review and meta-analysis of Patient-Rated Wrist (and Hand) Evaluation (PRWE/PRWHE) measurement properties, translation, and/ or cross-cultural adaptation. Disabil Rehabil. 2022 Nov;44(22):6551-6565. doi: 10.1080/09638288.2021.1970250. Epub 2021 Sep 10.
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/22/0128
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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