Clinical trial NCT01921062: Motor Imagery in Rehabilitation After a Distal Radius Fracture
Official title: Kinesthetic Motor Imagery Training During Immobilization to Improve Wrist Functional Outcome After a Distal Radius Fracture in Women of 45-75 Years of Age
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Distal Radius Fracture
Keywords: Distal radius fracture
Motor imagery
Immobilisation
Effectivity
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2013-08-13
Enrollment: 66
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine whether motor imagery training during the immobilisation period in patients with a distal radius fracture, results in an improved functional outcome compared to patients who do not perform motor imagery.

Detailed description: Rationale: Distal radius fracture (DRF) is a common injury that may lead to prolonged function restrictions, decreased range of motion, reduced grip strength and pain. These symptoms may be caused by physical changes due to the injury and/or by the 4-6 weeks immobilization that is part of the conservative treatment. However, it might also be that neural changes during the immobilization play an important role. Such changes might be prevented by motor imagery training during the immobilization period. So, when neural changes are prevented, this may lead to a better functional outcome.

Objective: The objective is to improve the functional outcome in distal radius fracture patients, specified as an increase in function, dexterity, grip strength, range of motion, and decrease of pain.

Study design: Parallel group randomized controlled trial, with a post-test only control group design. Patients in the experimental group perform motor imagery training during the immobilization period, in addition to the regular treatment. Patients in the control group receive regular treatment.

Study population: Female DRF-patients who are conservatively treated by a cast, aged 45-75 years. The fracture must be a low energy trauma caused by a fall. Patients with a score higher than 72 on the Vividness of Motor Imagery Questionnaire (VMIQ) are excluded, as well as patients with co-morbidities that might influence the wrist function, or motor imagery-ability, and patients with no understanding of Dutch language. The patients are randomly allocated to the experimental or control group by restricted randomization to ensure equal group sizes.

Intervention: Motor imagery training during the immobilization period).

Main study parameters/endpoints: The main study parameter is function. Secondary study parameters are dexterity, range of motion, grip strength, and pain.

Eligibility criteria: Inclusion Criteria:

* female patients
* non-comminutive distal radius fracture
* 45 to 75 years of age

Exclusion Criteria:

* distal radius fracture caused by HET
* comorbidities possibly influencing wrist function
* comorbidities possibly influencing motor imagery ability
* score higher than 72 on the Vividness of Motor Imagery Questionnaire

Primary outcomes:
measure: Hand Function
timeFrame: 2 days after cast removal
Secondary outcomes:
Other outcomes:
measure: Grip Strength (Difference Unaffected - Affected)
timeFrame: 2 weeks after cast removal
measure: Dexterity
timeFrame: Directly after cast removal
measure: Current Pain Level
timeFrame: Directly after cast removal
measure: Pain Relief
timeFrame: Directly after cast removal
measure: Range of Motion
timeFrame: Directly after cast removal.
measure: Hand Function
timeFrame: 2 weeks after cast removal
measure: Grip Strength
timeFrame: Directly after cast removal
measure: Dexterity
timeFrame: 2 weeks after cast removal
measure: Current Pain Level
timeFrame: 2 weeks after cast removal
measure: Pain Relief
timeFrame: 2 weeks after cast removal
measure: Range of Motion
timeFrame: 2 weeks after cast removal.
Locations:
city: Groningen
country: Netherlands
facility: University Medical Centre Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Martin W. Stenekes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Broekstra DC, Mouton LJ, van der Sluis CK, IJpma FFA, Stenekes MW. Hand function in patients with distal radius factures after home-based kinaesthetic motor imagery training. J Hand Surg Eur Vol. 2022 Jun;47(6):656-658. doi: 10.1177/17531934221075945. Epub 2022 Feb 1. No abstract available.