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Effects of Concentric Exercise With and Without Mulligan Wrist Mobilization After Distal Radius Fracture.

Primary Purpose

Distal Radius Fracture

Status
Not yet recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Concentric exercises with wrist mobilization
Concentric exercises without wrist mobilization
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture focused on measuring Disability, Range of Movement, Concentric exercises, Movement, Fracture

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • DHQ Hospital Sheikhupura

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Concentric exercises with wrist mobilization

Concentric exercises without wrist mobilization

Arm Description

concentric exercise including wrist flexion, extension, and abduction, adduction, supination and pronation plus wrist mobilizations with movements

concentric exercise including wrist flexion, extension, and abduction, adduction, supination and pronation

Outcomes

Primary Outcome Measures

Wrist Pain
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").
Grip Strength
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
Range of motion
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
Wrist Function
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

Secondary Outcome Measures

Full Information

First Posted
May 31, 2022
Last Updated
May 31, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05405023
Brief Title
Effects of Concentric Exercise With and Without Mulligan Wrist Mobilization After Distal Radius Fracture.
Official Title
Effects of Concentric Exercise With and Without Mulligan Wrist Mobilization on Pain, Grip Strength, Range of Motion and Function After Distal Radius Fracture.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 27, 2022 (Anticipated)
Primary Completion Date
November 27, 2022 (Anticipated)
Study Completion Date
January 27, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture
Keywords
Disability, Range of Movement, Concentric exercises, Movement, Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Concentric exercises with wrist mobilization
Arm Type
Experimental
Arm Description
concentric exercise including wrist flexion, extension, and abduction, adduction, supination and pronation plus wrist mobilizations with movements
Arm Title
Concentric exercises without wrist mobilization
Arm Type
Active Comparator
Arm Description
concentric exercise including wrist flexion, extension, and abduction, adduction, supination and pronation
Intervention Type
Other
Intervention Name(s)
Concentric exercises with wrist mobilization
Intervention Description
Participants will receive concentric exercise including wrist flexion, extension, and abduction, adduction, supination and pronation plus wrist mobilizations with movements.
Intervention Type
Other
Intervention Name(s)
Concentric exercises without wrist mobilization
Intervention Description
Participants will receive concentric exercises only.
Primary Outcome Measure Information:
Title
Wrist Pain
Description
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").
Time Frame
4 weeks
Title
Grip Strength
Description
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
Time Frame
4 weeks
Title
Range of motion
Description
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
Time Frame
4 weeks
Title
Wrist Function
Description
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
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, Phd
Phone
+923324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saba Rafique, Phd*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
DHQ Hospital Sheikhupura
City
Sheikhupura
State/Province
Punjab
ZIP/Postal Code
39350
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saba Rafique, Phd*
Phone
+923034045433
Email
saba.rafique@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Iqra Shahzadi, MsPT (OMPT)

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25657938
Citation
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.
Results Reference
background
PubMed Identifier
32193679
Citation
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.
Results Reference
background
PubMed Identifier
28342739
Citation
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.
Results Reference
background
PubMed Identifier
34668847
Citation
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.
Results Reference
background
PubMed Identifier
34058884
Citation
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.
Results Reference
background
PubMed Identifier
33144249
Citation
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.
Results Reference
background
PubMed Identifier
32070793
Citation
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.
Results Reference
background
PubMed Identifier
32291223
Citation
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.
Results Reference
background
PubMed Identifier
34776165
Citation
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.
Results Reference
background
PubMed Identifier
31477334
Citation
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.
Results Reference
background
PubMed Identifier
34505793
Citation
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.
Results Reference
background

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Effects of Concentric Exercise With and Without Mulligan Wrist Mobilization After Distal Radius Fracture.

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