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

Primary Purpose

Osteoporotic Distal Radius Fracture

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
motor cognitive therapies
Sponsored by
University of Stuttgart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporotic Distal Radius Fracture focused on measuring osteoporosis, wrist fracture, mental practice, mirror therapy, immobilization, elderly

Eligibility Criteria

65 Years - 85 Years (Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Robert Bosch Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Mental Practice

Mirror Therapy

Relaxation training

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Patient pain and disability
Patient Rated Wrist Evaluation (PRWE)

Secondary Outcome Measures

subjective hand function
Disabilities of the Arm and Shoulder (DASH)
objective measurements
Range of motion measurements & grip strength
subjective well-being
EQ5D

Full Information

First Posted
July 12, 2011
Last Updated
December 2, 2014
Sponsor
University of Stuttgart
Collaborators
German Federal Ministry of Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT01394809
Brief Title
Effects of Motor Cognitive Training on Functional Loss After Osteoporotic Wrist Fractures
Acronym
PROFinD-TP4
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

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Stuttgart
Collaborators
German Federal Ministry of Education and Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporotic Distal Radius Fracture
Keywords
osteoporosis, wrist fracture, mental practice, mirror therapy, immobilization, elderly

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mental Practice
Arm Type
Experimental
Arm Description
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.
Arm Title
Mirror Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Relaxation training
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
motor cognitive therapies
Intervention Description
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)
Primary Outcome Measure Information:
Title
Patient pain and disability
Description
Patient Rated Wrist Evaluation (PRWE)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
subjective hand function
Description
Disabilities of the Arm and Shoulder (DASH)
Time Frame
12 weeks
Title
objective measurements
Description
Range of motion measurements & grip strength
Time Frame
12 weeks
Title
subjective well-being
Description
EQ5D
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadja Schott, phd
Organizational Affiliation
University of Stuttgart
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robert Bosch Medical Center
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
25175985
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.
Results Reference
background
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.
Results Reference
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Effects of Motor Cognitive Training on Functional Loss After Osteoporotic Wrist Fractures

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