Distal Radius FractureNCT04820114
Proprioception and Multi Sensory Training After DRF
A study testing Proprioceptive wrist exercises and Wrist exercises in people with Distal Radius Fracture and Wrist Fracture, run by University of Malaga at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Radius Fracture, Wrist Fracture
- What is being tested?
- Proprioceptive wrist exercises and Wrist exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2021to 1 Jan 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient diagnosis of distal radius fracture.
- Wrist immobilization after lesion (unless 3 weeks)
- Capacity for sing inform concept and understand the exercises
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Raquel Cantero-Téllez
Málaga, Málaga, 29012
Raquel Cantero-Téllez, +34606267101, cantero@uma.es
About this study
Official title: The Role of Proprioception and Multi Sensory Training on Recovery and Patient Satisfaction After Distal Radius Fracture. Randomized Control Trial.
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.
Read the 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. 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.
- Conditions
- Distal Radius Fracture, Wrist Fracture
- Being tested
- Proprioceptive wrist exercises, Wrist exercises
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive wrist exercisesOther
Exercises for recognition of writs position and thumb force sense.
Wrist exercisesOther
Passive and active exercises for improve range of motion in flexion, extension, ulnar and radial deviation
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Wrist passive mobilizations; Actives exercises; Reeducation for Activity daily life. Receives: Other: Wrist exercises |
| Experimental group | Experimental | The experimental group will also carried out a proprioceptive exercise program divided in three phases of 2 weeks per phase. Receives: Other: Proprioceptive wrist exercises; Other: Wrist exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline-6 months
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.
Measured: Baseline- 3 months
Secondary outcomes (3)
Visual Analogue Scale (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.
Measured: Baseline-3 months
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.
Measured: Baseline-3 months
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.
Measured: Baseline-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start1 Apr 2021
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raquel Cantero-Téllez, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820114
- Sponsor's protocol ID
- Wrist 1 UMA
- Status last verified
- Apr 2021
- First submitted
- 24 Mar 2021
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Proprioception and Multi Sensory Training on Recovery and Patient Satisfaction After Distal Radius Fracture. Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT04820114
- Acronym / sponsor ID
- Wrist 1 UMA
- Conditions
- Distal Radius Fracture, Wrist Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 29 Mar 2021 (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.
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. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Wrist exercisesWrist passive mobilizations; Actives exercises; Reeducation for Activity daily life. |
| Experimental group | Experimental | Other: Proprioceptive wrist exercises, Other: Wrist exercisesThe experimental group will also carried out a proprioceptive exercise program divided in three phases of 2 weeks per phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient diagnosis of distal radius fracture.
- Wrist immobilization after lesion (unless 3 weeks)
- Capacity for sing inform concept and understand the exercises
Key exclusion criteria (4 listed)
- 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.
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 wrist exercisesExercises for recognition of writs position and thumb force sense. | Other | Experimental group |
| Wrist exercisesPassive and active exercises for improve range of motion in flexion, extension, ulnar and radial deviation | Other | Control group, Experimental group |
Primary outcome
Joint position Sense (JPS)
Time frame: Baseline-6 months
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)
Time frame: Baseline- 3 months
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.
3 secondary outcomes
Visual Analogue Scale (VAS)
Time frame: Baseline-3 months
Canadian Occupational Performance Measure
Time frame: Baseline-3 months
PRWE Patient review wrist evaluation
Time frame: Baseline-3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive wrist exercises and Wrist exercises in people with Distal Radius Fracture and Wrist Fracture, run by University of Malaga at 1 site in Spain.
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 4 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 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Raquel Cantero, PhD (0034 951952850, cantero@uma.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint position Sense (JPS) (time frame: Baseline-6 months). The study lists 2 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 30 Apr 2021.