- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06132646
Proprioceptive Training Following a Wrist Fracture
Effectiveness of a Global Proprioceptive Training After Wrist Fracture
The goal of this randomized clinical trial is to compare how a program of proprioceptive exercises for the wrist could influence in pain, functionality and quality of life in people that have suffered a wrist fracture. The main questions it aims to answer are:
- Evaluate the effect of a specific proprioceptive program on pain and functionality.
- Study the relationship between proprioception deficit and functionality.
Intervention will be:
- Control group: participants of this group are going to receive only standard rehabilitation program after wrist fracture.
- Experimental group: participants of this group are going to receive standard rehabilitation program after distal radius fracture and a specific proprioceptive program.
Researchers will compare control and experimental group to see if a implantation of a proprioceptive program for the wrist has benefits on pain, function and quality of life.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Distal radius fracture (DRF) is one of the most frequent injuries in the upper limb, corresponding to 1/6 of the total fractures of the body. It appears mostly in >50 years old women (due to osteoporosis and menopause) but it is also frequent in middle age men as a consequence of a big trauma during sport activities or working. This injury can be treated conservative of surgically, but regardless of the treatment, it always has a period of immobilization between 3 and 6 weeks.
The term "proprioception" was firstly described by Sherrington in 1906 as "perception" of body position and movement. The presence and quantity of mechanoreceptors in the joint determine its proprioceptive capacity. In the 1990s, the presence of mechanoreceptors on the wrist was described, and subsequent studies allowed us to determine that the dorsal and ulnar ligaments of the wrist have a rich innervation of mechanoreceptors. With these findings, we can hypothesize various clinical applications, both for working on wrist proprioception in the early stages of proprioceptive reeducation without risking tissue damage and for neuromuscular work after fracture consolidation, with the goal of regaining fluid and balanced movement. Previous studies on the ankle, knee, and shoulder have shown that the implementation of a proprioceptive program in the rehabilitation process can improve traumatic instability and pain. Given that the wrist shares similarities with these joints in terms of proprioceptive innervation, we can hypothesize that a specific proprioceptive exercise program for the wrist may be beneficial in the recovery after a wrist fracture.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult (equal or more than 18 y/o).
- Suffering a wrist fracture and have passed immobilization period.
- Agree and sign informed consent.
Exclusion Criteria:
- Not had suffered a wrist fracture, being in the immobilization period or not authorized by his/her orthopedic surgeon to start with rehabilitation.
- Suffer any mental, cognitive, neurological or musculoskeletal disorder.
- Previous injury or pathology of the upper limb affected.
- Previos surgery on the upper limb affected.
- Have cervical pathology/impairment.
- Suffering from blindness.
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 |
---|---|
No Intervention: Control group
Patients that had suffered a wrist fracture and are going to receive standard rehabilitation for the wrist.
|
|
Experimental: Experimental group
Patients that had suffered a wrist fracture and are going to receive standard rehabilitation for the wrist.
|
Specific proprioceptive exercises for the wrist that the patient has to do currently with standard rehabilitation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in function related with daily living activities
Time Frame: Baseline, 4 weeks and 3 months.
|
Measured with QuickDASH.
11 items, 0=no disability and 100= total disability
|
Baseline, 4 weeks and 3 months.
|
Change in perception of pain, referred to wrist
Time Frame: Baseline, 4 weeks and 3 months
|
Pain measured with Numerical Rating Scale (NRS) 0= no pain and 10=worst pain
|
Baseline, 4 weeks and 3 months
|
Change in hand and wrist function related with difficulties in performing daily living activities
Time Frame: Baseline, 4 weeks and 3 months
|
Measured with Patient-rated wrist evaluation (PRWE).
15 items in 2 subscales, function (10 items) and pain (5 items).
Punctuation could be from 0 to 50 in each subscale, where 50 points means worse pain/function.
|
Baseline, 4 weeks and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in range of motion of the wrist
Time Frame: Baseline, 4 weeks and 3 months.
|
Active range of motion of the wrist in all planes of motion.
Assessed with a goniometer.
|
Baseline, 4 weeks and 3 months.
|
Change in strength
Time Frame: Baseline, 4 weeks and 3 months.
|
GRIP force.
Assessed with a Jamar Dynamometer.
|
Baseline, 4 weeks and 3 months.
|
Change in Perception of Quality of life
Time Frame: Baseline, 4 weeks and 3 months
|
EuroQol-5D.
It has 5 dimensions, mobility, self-care, daily activities, pain and anxiety and depression.
Patient determines the level of agreement with the affirmations (3 options).
|
Baseline, 4 weeks and 3 months
|
Changes in proprioception, position terms
Time Frame: Baseline, 4 weeks and 3 months
|
Measured with Joint Position Sense Test (JPST).
|
Baseline, 4 weeks and 3 months
|
Changes in proprioception, strength terms
Time Frame: Baseline, 4 weeks and 3 months
|
Measured with Force Sense Test
|
Baseline, 4 weeks and 3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- RaqCan342
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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