Proprioceptive Training Following a Wrist Fracture

NCT06132646 | Unknown

• 1 other identifier: RaqCan342
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Wrist Fractures; Pain

Keywords

Proprioceptive exercises; Function; Wrist fracture

Outcome Measures

Primary Outcomes (3)

• 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.

• 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

• 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 Outcomes (5)

• Change in range of motion of the wrist

  Baseline, 4 weeks and 3 months.

• Change in strength

  Baseline, 4 weeks and 3 months.

• Change in Perception of Quality of life

  Baseline, 4 weeks and 3 months

• Changes in proprioception, position terms

  Baseline, 4 weeks and 3 months

• Changes in proprioception, strength terms

  Baseline, 4 weeks and 3 months

Study Arms (2)

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.

Other: Proprioceptive exercises

Interventions

Proprioceptive exercises OTHER

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

Experimental group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (equal or more than 18 y/o).
• Suffering a wrist fracture and have passed immobilization period.
• Agree and sign informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaga: lead

MeSH Terms

Conditions

Wrist Fractures; Pain

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be anonymized with a number and randomized with a web program (random.org)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 15, 2023
• Study Start: January 7, 2024
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2024
• Last Updated: November 15, 2023

Record last verified: 2023-11