Effects of Motor Cognitive Training on Functional Loss After Osteoporotic Wrist Fractures (PROFinD-TP4)

Effects of Motor Cognitive Training on Functional Loss Through Immobilization After Osteoporotic Distal Radius Fractures: a Randomised Clinical Pilot Study in Elderly Patients

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).

Study Overview

• Status: Completed
• Conditions: Osteoporotic Distal Radius Fracture
• Intervention / Treatment: Behavioral: motor cognitive therapies

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Stuttgart, Germany, 70376
    • Robert Bosch Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient pain and disability	Patient Rated Wrist Evaluation (PRWE)	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
subjective hand function	Disabilities of the Arm and Shoulder (DASH)	12 weeks
objective measurements	Range of motion measurements & grip strength	12 weeks
subjective well-being	EQ5D	12 weeks

Collaborators and Investigators

• Sponsor: University of Stuttgart
• Collaborators: German Federal Ministry of Education and Research
• Investigators: Principal Investigator: Nadja Schott, phd, University of Stuttgart

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: July 12, 2011
• First Submitted That Met QC Criteria: July 13, 2011
• First Posted (Estimate): July 14, 2011

Study Record Updates

• Last Update Posted (Estimate): December 4, 2014
• Last Update Submitted That Met QC Criteria: December 2, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: elderly; osteoporosis; mirror therapy; wrist fracture; mental practice; immobilization
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: 01 EC 1007D