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

NCT ID: NCT01394809

Last Updated: 2014-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2014-10-31

Brief Summary

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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).

Detailed Description

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Conditions

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Osteoporotic Distal Radius Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

motor cognitive therapies

Intervention Type 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)

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.

Group Type EXPERIMENTAL

motor cognitive therapies

Intervention Type 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)

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.

Group Type ACTIVE_COMPARATOR

motor cognitive therapies

Intervention Type 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)

Interventions

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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)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role collaborator

University of Stuttgart

OTHER

Sponsor Role lead

Responsible Party

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Nadja Schott

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nadja Schott, phd

Role: PRINCIPAL_INVESTIGATOR

University of Stuttgart

Locations

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Robert Bosch Medical Center

Stuttgart, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 25175985 (View on PubMed)

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.

Reference Type BACKGROUND

Other Identifiers

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01 EC 1007D

Identifier Type: -

Identifier Source: org_study_id