Thumb and Wrist Proprioception Exercises.
Primary Purpose
Radius Fractures, Hand Injuries, Pain, Chronic
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Thumb active Exercises
Sponsored by
About this trial
This is an interventional treatment trial for Radius Fractures
Eligibility Criteria
Inclusion Criteria:
- Patient diagnosis of distal radius fracture.
- Wrist immobilization after lesion (unless 3 weeks)
- Capacity for sing inform concept and understand the exercises
Exclusion Criteria:
- Others associate fractures in hand or upper limb
- Wrist ligaments injuries
- Neurological disorder affecting the upper limb
- Have received previous proprioceptive training for upper limb injury.
Sites / Locations
- Raquel Cantero-Téllez
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group
Experimental group
Arm Description
Wrist passive mobilizations; Actives exercises; Reeducation for Activity daily life;
The experimental group will also carried out a proprioceptive exercise home program with a laptop.
Outcomes
Primary Outcome Measures
Joint position Sense (JPS)
Proprioception using active joint position sense (JPS) has been utilized in studies to establish a correlation between therapy intervention and proprioception. Joint angle will be measured using a standard clear plastic goniometer.
Force sense (FS)
Muscle strength (MS) is one of the most important factors affecting human performance. Force sense (FS) is also known as sense of effort / heaviness / tension or the force matching sense. It is the ability to reproduce (or match) a desired level of force one or more times.
Secondary Outcome Measures
Pain (VAS)
VAS has been shown to be a reliable and valid instrument for pain assessment which is used frequently for clinical and research purposes. It consists of a 10-cm line anchored at each end. The left-hand anchor reads 'no pain' and the right-hand anchor reads 'worst possible pain'; the patients marked a line to represent their pain level.
Canadian Occupational Performance Measure
Patient's occupational performance will be measured with the Canadian Occupational Performance Measure (COPM). The COPM enables subjects to identify goals for hand therapy and engage in a subject-specific therapeutic process.
PRWE Patient review wrist evaluation
PRWE is the Patient-Rated Wrist Evaluation, It is one of the reliable upper extremity outcome instrument.The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. Developed in 1998 for clinical assessment and is used for specific wrist problems.
Dexterity test. Purdue pegboard
This manipulative dexterity test contains twenty-five holes with randomly positioned slots and pegs which have a key along one side. Pegs must be rotated to match the hole before they can be inserted.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04930718
Brief Title
Thumb and Wrist Proprioception Exercises.
Official Title
Thumb and Wrist Proprioception Exercises to Improve Pain Sensibility and Manual Dexterity After Distal Radius Fracture.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2021 (Anticipated)
Primary Completion Date
July 20, 2021 (Anticipated)
Study Completion Date
September 20, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaga
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
Distal radius fracture is the most common upper extremity fracture with peak incidence among older women after the fifth decade of life. Proprioception is one constituent of a complex Sensory motor control process. Proprioception requires the reception and central integration of incoming afferent signals. Although various sensory and motor deficits have been correlated with significant functional impairment after wrist trauma, limited research exists on the effects of proprioception and multi sensory training after distal radius fracture.
Detailed Description
A randomized, controlled, single-center, double-blind, clinical trial, with 1:1 allocation ratio, will be carried out involving patients diagnosis of distal radius fracture (aged 18 years and above). Both assessor and statistician will remained blinded.
Standard rehabilitation program for distal radius fracture treatments will received for both the control and experimental groups for a period of 12 weeks. The experimental group, in addition, will received a proprioceptive training program during the same intervention period, which will be conducted twice weekly (24 sessions).
The severity of pain with activity will be measured according to the visual analog scale (VAS). PRWE questionnaire will be used to measure upper extremity function. Patient's occupational performance will be measured with the Canadian Occupational Performance Measure (COPM) and proprioception with Joint position sense (JPS) and force sense (FS) testing, for dexterity Due pegboard test will be used. All outcome measures will be collected at baseline, immediately following the intervention at 3 weeks and at 12 weeks following the end of the intervention.
Participation in the study will be voluntary and patients will be included if they satisfied specific inclusion criteria.
All procedures will be follow in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration. All participants will sign a written informed consent in accordance with guidelines approved by the local ethics committee.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radius Fractures, Hand Injuries, Pain, Chronic, Proprioceptive Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
47 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Wrist passive mobilizations; Actives exercises; Reeducation for Activity daily life;
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
The experimental group will also carried out a proprioceptive exercise home program with a laptop.
Intervention Type
Other
Intervention Name(s)
Thumb active Exercises
Intervention Description
Active específico exercises; Reeducation program
Primary Outcome Measure Information:
Title
Joint position Sense (JPS)
Description
Proprioception using active joint position sense (JPS) has been utilized in studies to establish a correlation between therapy intervention and proprioception. Joint angle will be measured using a standard clear plastic goniometer.
Time Frame
baseline-3 months
Title
Force sense (FS)
Description
Muscle strength (MS) is one of the most important factors affecting human performance. Force sense (FS) is also known as sense of effort / heaviness / tension or the force matching sense. It is the ability to reproduce (or match) a desired level of force one or more times.
Time Frame
baseline-3 months
Secondary Outcome Measure Information:
Title
Pain (VAS)
Description
VAS has been shown to be a reliable and valid instrument for pain assessment which is used frequently for clinical and research purposes. It consists of a 10-cm line anchored at each end. The left-hand anchor reads 'no pain' and the right-hand anchor reads 'worst possible pain'; the patients marked a line to represent their pain level.
Time Frame
baseline-3 months
Title
Canadian Occupational Performance Measure
Description
Patient's occupational performance will be measured with the Canadian Occupational Performance Measure (COPM). The COPM enables subjects to identify goals for hand therapy and engage in a subject-specific therapeutic process.
Time Frame
baseline-3 months
Title
PRWE Patient review wrist evaluation
Description
PRWE is the Patient-Rated Wrist Evaluation, It is one of the reliable upper extremity outcome instrument.The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. Developed in 1998 for clinical assessment and is used for specific wrist problems.
Time Frame
baseline-3 months
Title
Dexterity test. Purdue pegboard
Description
This manipulative dexterity test contains twenty-five holes with randomly positioned slots and pegs which have a key along one side. Pegs must be rotated to match the hole before they can be inserted.
Time Frame
baseline-3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient diagnosis of distal radius fracture.
Wrist immobilization after lesion (unless 3 weeks)
Capacity for sing inform concept and understand the exercises
Exclusion Criteria:
Others associate fractures in hand or upper limb
Wrist ligaments injuries
Neurological disorder affecting the upper limb
Have received previous proprioceptive training for upper limb injury.
Facility Information:
Facility Name
Raquel Cantero-Téllez
City
Malaga
State/Province
Málaga
ZIP/Postal Code
29012
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Thumb and Wrist Proprioception Exercises.
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