Stability and Balance in Locomotion Through Exercise

NCT ID: NCT01856244

Last Updated: 2016-10-05

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

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-06-30

Brief Summary

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Persons with Morbus Parkinson commonly develop gait and balance disorders leading to dependence, loss of mobility and a high risk of falling.

This study investigates the effectiveness of a sensorimotor treadmill intervention to improve walking and balance abilities in persons with early stages of Parkinson's disease. The sensorimotor treadmill training is conducted on a special treadmill device which is challenging the participants by small oscillations. This intervention, which is supposed to simulate walking on natural, uneven surfaces, is compared to a conventional treadmill training.

Hypothesis: Sensorimotor treadmill training leads to larger improvements in walking and balance abilities as compared to conventional treadmill exercise.

Detailed Description

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Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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sensorimotor treadmill training

specific treadmill control using oscillating platform

Group Type EXPERIMENTAL

treadmill walking

Intervention Type BEHAVIORAL

Treadmill

Intervention Type DEVICE

conventional treadmill training

conventional treadmill control

Group Type ACTIVE_COMPARATOR

treadmill walking

Intervention Type BEHAVIORAL

Treadmill

Intervention Type DEVICE

Interventions

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treadmill walking

Intervention Type BEHAVIORAL

Treadmill

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Parkinson's disease stage 1-3 Hoehn and Yahr
* United Parkinson Disease Rating Scale (UPDRS) 'gait' or 'postural stability' subscore of 1 or more
* Ability to stand unaided and walk without an assistive device
* Stable medication during the study period

Exclusion Criteria

* On-off and wearing-off phenomena
* Unstable medical or psychiatric illness
* Clinically relevant cardiovascular or orthopaedic disease
* Severe polyneuropathy
* Cognitive impairment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Foundation for Neurology

OTHER

Sponsor Role collaborator

Department of Molecular Neurology, Faculty of Medicine, University Erlangen-Nürnberg

OTHER

Sponsor Role collaborator

University of Erlangen-Nürnberg

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Klaus Pfeifer

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Klaus Pfeifer, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Institute of Sport Science and Sport

Locations

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Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Institute of Sport Science and Sport, Gebbertstr. 123b

Erlangen, , Germany

Site Status

Countries

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Germany

References

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Klamroth S, Steib S, Devan S, Pfeifer K. Effects of Exercise Therapy on Postural Instability in Parkinson Disease: A Meta-analysis. J Neurol Phys Ther. 2016 Jan;40(1):3-14. doi: 10.1097/NPT.0000000000000117.

Reference Type BACKGROUND
PMID: 26655098 (View on PubMed)

Klamroth S, Steib S, Gassner H, Gossler J, Winkler J, Eskofier B, Klucken J, Pfeifer K. Immediate effects of perturbation treadmill training on gait and postural control in patients with Parkinson's disease. Gait Posture. 2016 Oct;50:102-108. doi: 10.1016/j.gaitpost.2016.08.020. Epub 2016 Aug 26.

Reference Type RESULT
PMID: 27591395 (View on PubMed)

Other Identifiers

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DSN-0613

Identifier Type: -

Identifier Source: org_study_id

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