Effects of Motor Cognitive Training on Functional Loss After Osteoporotic Wrist Fractures
PROFinD-TP4
1 other identifier
interventional
27
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 12, 2011
CompletedFirst Posted
Study publicly available on registry
July 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedDecember 4, 2014
December 1, 2014
4.2 years
July 12, 2011
December 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient pain and disability
Patient Rated Wrist Evaluation (PRWE)
12 weeks
Secondary Outcomes (3)
subjective hand function
12 weeks
objective measurements
12 weeks
subjective well-being
12 weeks
Study Arms (3)
Mental Practice
EXPERIMENTALDuring 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.
Mirror Therapy
EXPERIMENTALMirror 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.
Relaxation training
ACTIVE COMPARATORThe 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.
Interventions
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 Criteria
You may qualify if:
- wrist fracture
- age 65 and older
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Robert Bosch Medical Center
Stuttgart, 70376, Germany
Related Publications (2)
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.
PMID: 25175985BACKGROUNDSchott, 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.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nadja Schott, phd
University of Stuttgart
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 12, 2011
First Posted
July 14, 2011
Study Start
August 1, 2010
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
December 4, 2014
Record last verified: 2014-12