Proprioceptive Training Following a Wrist Fracture

Sponsor
University of Malaga (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06132646
Collaborator
(none)
28
2
7.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Proprioceptive exercises
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
Participants will be anonymized with a number and randomized with a web program (random.org)
Primary Purpose:
Treatment
Official Title:
Effectiveness of a Global Proprioceptive Training After Wrist Fracture
Anticipated Study Start Date :
Jan 7, 2024
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

  1. Change in function related with daily living activities [Baseline, 4 weeks and 3 months.]

    Measured with QuickDASH. 11 items, 0=no disability and 100= total disability

  2. Change in perception of pain, referred to wrist [Baseline, 4 weeks and 3 months]

    Pain measured with Numerical Rating Scale (NRS) 0= no pain and 10=worst pain

  3. Change in hand and wrist function related with difficulties in performing daily living activities [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.

Secondary Outcome Measures

  1. Change in range of motion of the wrist [Baseline, 4 weeks and 3 months.]

    Active range of motion of the wrist in all planes of motion. Assessed with a goniometer.

  2. Change in strength [Baseline, 4 weeks and 3 months.]

    GRIP force. Assessed with a Jamar Dynamometer.

  3. Change in Perception of Quality of life [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).

  4. Changes in proprioception, position terms [Baseline, 4 weeks and 3 months]

    Measured with Joint Position Sense Test (JPST).

  5. Changes in proprioception, strength terms [Baseline, 4 weeks and 3 months]

    Measured with Force Sense Test

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Malaga

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Leire Cruz-Gambero, Principal Investigator, University of Malaga
ClinicalTrials.gov Identifier:
NCT06132646
Other Study ID Numbers:
  • RaqCan342
First Posted:
Nov 15, 2023
Last Update Posted:
Nov 15, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Leire Cruz-Gambero, Principal Investigator, University of Malaga
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 15, 2023