Clinical trial NCT01394809: Effects of Motor Cognitive Training on Functional Loss After Osteoporotic Wrist Fractures
Official title: Effects of Motor Cognitive Training on Functional Loss Through Immobilization After Osteoporotic Distal Radius Fractures: a Randomised Clinical Pilot Study in Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporotic Distal Radius Fracture
Keywords: osteoporosis
wrist fracture
mental practice
mirror therapy
immobilization
elderly
Lead sponsor: University of Stuttgart
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2011-07-14
Enrollment: 27
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The therapy results after distal radius fracture especially of elderly patients are often suboptimal. The central problem results from the inevitable, 3-6-weeks immobilization, which leads to reduction in ROM of the wrist, deterioration of muscle strength as well as malfunction of fine motor skills and coordination. Currently, there are no adequate proactive strategies to counteract these immobilisation problems. Hence the overall aim of our research project is to investigate the therapeutic potential of a motor-cognitive therapy on hand function after distal radius fracture. On the one hand the pilot study should provide information about the level of recruitment rate necessitated for an adequate sample size which allows reliable evidence for the therapy effects. On the other hand we want to evaluate the sensitivity and adequacy of the assessment instruments.

The pilot is conceived as a controlled, randomised, longitudinal intervention study over 6 weeks with 3 groups. One experimental group imagine movements and actions without executing them. A second experimental group performs mirror training, in which visual feedback through a mirror activates additionally the contralateral hemisphere. The control group receives therapy as usual. There are three key domains to be analysed: function (PRWE), impairment (ROM, strength) and participation in social life/life quality (DASH, EQ5D).


Eligibility criteria: Inclusion Criteria:

* wrist fracture
* age 65 and older

Exclusion Criteria:

* unstable medical conditions which preclude surgical intervention (ASA 5)
* Patients who do not live independently (nursing home)
* Patients with an open fracture
* Associated soft tissue or skeletal injury to the same limb
* Cognitive impairment (6CIT \< 10)

Primary outcomes:
measure: Patient pain and disability
timeFrame: 12 weeks
Secondary outcomes:
measure: subjective hand function
timeFrame: 12 weeks
measure: objective measurements
timeFrame: 12 weeks
measure: subjective well-being
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Robert Bosch Medical Center
Study officials:
affiliation: University of Stuttgart
name: Nadja Schott, phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schott N, Korbus H. Preventing functional loss during immobilization after osteoporotic wrist fractures in elderly patients: a randomized clinical trial. BMC Musculoskelet Disord. 2014 Aug 30;15:287. doi: 10.1186/1471-2474-15-287.
citation: Schott, N., Frenkel, M.-O., Korbus, H. & Francis, K. (2013). Mental Practice in Orthopaedic Rehabilitation: Where, What, and How? A case report. Sci-ence et Motricité, 82, 93-103.