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OpenTrials
Completed

NCT Number: NCT01394809

Effects of Motor Cognitive Training on Functional Loss After Osteoporotic Wrist Fractures

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).

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Key information

Age range

65 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Robert Bosch Medical Center

Stuttgart, 70376, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

motor cognitive therapies

Behavioral

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 outcomes

  1. Patient pain and disability

    Time frame: 12 weeks

    Patient Rated Wrist Evaluation (PRWE)

Secondary outcomes

  1. subjective hand function

    Time frame: 12 weeks

    Disabilities of the Arm and Shoulder (DASH)

  2. objective measurements

    Time frame: 12 weeks

    Range of motion measurements & grip strength

  3. subjective well-being

    Time frame: 12 weeks

    EQ5D

Sponsors and collaborators

Lead sponsor

University of Stuttgart

Other

Collaborators

  • German Federal Ministry of Education and Research

Registry information

Official study title

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

Acronym: PROFinD-TP4

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jul 14, 2011
Registry last updated
Dec 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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