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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06132646
Other study ID # RaqCan342
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 7, 2024
Est. completion date September 1, 2024

Study information

Verified date November 2023
Source University of Malaga
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 28
Est. completion date September 1, 2024
Est. primary completion date August 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Proprioceptive exercises
Specific proprioceptive exercises for the wrist that the patient has to do currently with standard rehabilitation.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Malaga

Outcome

Type Measure Description Time frame Safety issue
Primary Change in function related with daily living activities Measured with QuickDASH. 11 items, 0=no disability and 100= total disability Baseline, 4 weeks and 3 months.
Primary Change in perception of pain, referred to wrist Pain measured with Numerical Rating Scale (NRS) 0= no pain and 10=worst pain Baseline, 4 weeks and 3 months
Primary 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. Baseline, 4 weeks and 3 months
Secondary Change in range of motion of the wrist Active range of motion of the wrist in all planes of motion. Assessed with a goniometer. Baseline, 4 weeks and 3 months.
Secondary Change in strength GRIP force. Assessed with a Jamar Dynamometer. Baseline, 4 weeks and 3 months.
Secondary 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). Baseline, 4 weeks and 3 months
Secondary Changes in proprioception, position terms Measured with Joint Position Sense Test (JPST). Baseline, 4 weeks and 3 months
Secondary Changes in proprioception, strength terms Measured with Force Sense Test Baseline, 4 weeks and 3 months
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