Effects of Motor Cognitive Training on Functional Loss After Osteoporotic Wrist Fractures (PROFinD-TP4)
Recruitment status was Recruiting
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Osteoporotic Distal Radius Fracture |
Behavioral: motor cognitive therapies |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
- Patient pain and disability [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Patient Rated Wrist Evaluation (PRWE)
- subjective hand function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Disabilities of the Arm and Shoulder (DASH)
- objective measurements [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Range of motion measurements & grip strength
- subjective well-being [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]EQ5D
| Estimated Enrollment: | 36 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Mental Practice
During motor imagery practice a person imagines performing a movement with all its sensory consequences without actually moving. In this study the therapists follow a motor imagery guideline designed for rehabilitation of movement performance. The guideline offers therapists structure and a strategy to deliver subject-specific imagery, and is based on principles of motor learning.
|
Behavioral: motor cognitive therapies
pre-test; 6 weeks intervention: week 1-3: 5 times per week 60 minutes a day. Week 4-6: 3 times per week 60 minutes a day; post-test; follow-up)
|
|
Experimental: Mirror Therapy
Mirror therapy is thought to work by using vision of the intact or good arm to replace or drive proprioception in the affected arm, and so normalise the afferent segment of the movement process.
|
Behavioral: motor cognitive therapies
pre-test; 6 weeks intervention: week 1-3: 5 times per week 60 minutes a day. Week 4-6: 3 times per week 60 minutes a day; post-test; follow-up)
|
|
Active Comparator: Relaxation training
The control group will receive therapy as usual. Currently, this means that patients are immobilized during first 3-4 weeks. The control group will receive additional relaxation training during this period to achieve the same total amount of time the therapist spends with the patients of the experimental groups.
|
Behavioral: motor cognitive therapies
pre-test; 6 weeks intervention: week 1-3: 5 times per week 60 minutes a day. Week 4-6: 3 times per week 60 minutes a day; post-test; follow-up)
|
Eligibility| Ages Eligible for Study: | 65 Years to 85 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| Contact: Heide Korbus, Msc | +49711685 ext 60530 | heide.korbus@inspo.uni-stuttgart.de |
| Germany | |
| Robert Bosch Medical Center | Recruiting |
| Stuttgart, Germany, 70376 | |
| Contact: Heide Korbus, Msc +49711685 ext 60530 heide.korbus@inspo.uni-stuttgart.de | |
| Sub-Investigator: Clemens Becker, phd | |
| Principal Investigator: | Nadja Schott, phd | University of Stuttgart |
More Information
No publications provided
| Responsible Party: | Prof. Dr. Nadja Schott, University of Stuttgart |
| ClinicalTrials.gov Identifier: | NCT01394809 History of Changes |
| Other Study ID Numbers: | 01 EC 1007D |
| Study First Received: | July 12, 2011 |
| Last Updated: | July 13, 2011 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by University of Stuttgart:
|
osteoporosis wrist fracture mental practice |
mirror therapy immobilization elderly |
Additional relevant MeSH terms:
|
Fractures, Bone Radius Fractures Wounds and Injuries Forearm Injuries Arm Injuries |
ClinicalTrials.gov processed this record on June 17, 2013