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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of Stuttgart.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by:
University of Stuttgart
ClinicalTrials.gov Identifier:
NCT01394809
First received: July 12, 2011
Last updated: July 13, 2011
Last verified: April 2011
  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

Resource links provided by NLM:


Further study details as provided by University of Stuttgart:

Primary Outcome Measures:
  • Patient pain and disability [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Patient Rated Wrist Evaluation (PRWE)


Secondary Outcome Measures:
  • 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
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394809

Contacts
Contact: Heide Korbus, Msc +49711685 ext 60530 heide.korbus@inspo.uni-stuttgart.de

Locations
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         
Sponsors and Collaborators
University of Stuttgart
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Nadja Schott, phd University of Stuttgart
  More Information

No publications provided by University of Stuttgart

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 October 19, 2014