NCT01394809

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2011

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

December 4, 2014

Status Verified

December 1, 2014

Enrollment Period

4.2 years

First QC Date

July 12, 2011

Last Update Submit

December 2, 2014

Conditions

Keywords

osteoporosiswrist fracturemental practicemirror therapyimmobilizationelderly

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

EXPERIMENTAL

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

Mirror Therapy

EXPERIMENTAL

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

Relaxation training

ACTIVE COMPARATOR

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

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)

Mental PracticeMirror TherapyRelaxation training

Eligibility Criteria

Age65 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

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

Location

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: 25175985BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

OsteoporosisWrist Fractures

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesWrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Nadja Schott, phd

    University of Stuttgart

    PRINCIPAL INVESTIGATOR

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

Locations