Wrist FracturesNCT06132646
Proprioceptive Training Following a Wrist Fracture
A study testing Proprioceptive exercises in people with Wrist Fractures and Pain, run by University of Malaga.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Wrist Fractures, Pain
- What is being tested?
- Proprioceptive exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 7 Jan 2024to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (equal or more than 18 y/o).
- Suffering a wrist fracture and have passed immobilization period.
- Agree and sign informed consent.
Who cannot join
- 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.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Wrist Fractures, Pain
- Being tested
- Proprioceptive exercises
- Keywords
- Proprioceptive exercises, Function, Wrist fracture
- Medical subject headings
- Wrist Fractures, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive exercisesOther
Specific proprioceptive exercises for the wrist that the patient has to do currently with standard rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Patients that had suffered a wrist fracture and are going to receive standard rehabilitation for the wrist. |
| Experimental group | Experimental | Patients that had suffered a wrist fracture and are going to receive standard rehabilitation for the wrist. Receives: Other: Proprioceptive exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in function related with daily living activities
Measured with QuickDASH. 11 items, 0=no disability and 100= total disability
Measured: Baseline, 4 weeks and 3 months.
Change in perception of pain, referred to wrist
Pain measured with Numerical Rating Scale (NRS) 0= no pain and 10=worst pain
Measured: Baseline, 4 weeks and 3 months
Change in hand and wrist function related with difficulties in performing daily living activities
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.
Measured: Baseline, 4 weeks and 3 months
Secondary outcomes (5)
Change in range of motion of the wrist
Active range of motion of the wrist in all planes of motion. Assessed with a goniometer.
Measured: Baseline, 4 weeks and 3 months.
Change in strength
GRIP force. Assessed with a Jamar Dynamometer.
Measured: Baseline, 4 weeks and 3 months.
Change in Perception of Quality of life
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).
Measured: Baseline, 4 weeks and 3 months
Changes in proprioception, position terms
Measured with Joint Position Sense Test (JPST).
Measured: Baseline, 4 weeks and 3 months
Changes in proprioception, strength terms
Measured with Force Sense Test
Measured: Baseline, 4 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start7 Jan 2024 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrist FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leire Cruz-Gambero, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132646
- Sponsor's protocol ID
- RaqCan342
- Status last verified
- Nov 2023
- First submitted
- 9 Nov 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Global Proprioceptive Training After Wrist Fracture
- ClinicalTrials.gov ID
- NCT06132646
- Acronym / sponsor ID
- RaqCan342
- Conditions
- Wrist Fractures, Pain
- Keywords
- Proprioceptive exercises, Function, Wrist fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 7 Jan 2024 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Patients that had suffered a wrist fracture and are going to receive standard rehabilitation for the wrist. |
| Experimental group | Experimental | Other: Proprioceptive exercisesPatients that had suffered a wrist fracture and are going to receive standard rehabilitation for the wrist. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (equal or more than 18 y/o).
- Suffering a wrist fracture and have passed immobilization period.
- Agree and sign informed consent.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proprioceptive exercisesSpecific proprioceptive exercises for the wrist that the patient has to do currently with standard rehabilitation. | Other | Experimental group |
Primary outcome
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
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
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.
5 secondary outcomes
Change in range of motion of the wrist
Time frame: Baseline, 4 weeks and 3 months.
Change in strength
Time frame: Baseline, 4 weeks and 3 months.
Change in Perception of Quality of life
Time frame: Baseline, 4 weeks and 3 months
Changes in proprioception, position terms
Time frame: Baseline, 4 weeks and 3 months
Changes in proprioception, strength terms
Time frame: Baseline, 4 weeks and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive exercises in people with Wrist Fractures and Pain, run by University of Malaga.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in function related with daily living activities (time frame: Baseline, 4 weeks and 3 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023; AzTrials last refreshed its copy on 6 Nov 2026.