Osteoporotic Distal Radius Fracture Clinical Trial
— PROFinD-TP4Official title:
Effects of Motor Cognitive Training on Functional Loss Through Immobilization After Osteoporotic Distal Radius Fractures: a Randomised Clinical Pilot Study in Elderly Patients
| Verified date | December 2014 |
| Source | University of Stuttgart |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Ethics Commission |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 27 |
| Est. completion date | October 2014 |
| Est. primary completion date | October 2014 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 65 Years to 85 Years |
| Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Robert Bosch Medical Center | Stuttgart |
| Lead Sponsor | Collaborator |
|---|---|
| University of Stuttgart | German Federal Ministry of Education and Research |
Germany,
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. — View 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.
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Patient pain and disability | Patient Rated Wrist Evaluation (PRWE) | 12 weeks | No |
| Secondary | subjective hand function | Disabilities of the Arm and Shoulder (DASH) | 12 weeks | No |
| Secondary | objective measurements | Range of motion measurements & grip strength | 12 weeks | No |
| Secondary | subjective well-being | EQ5D | 12 weeks | No |