NCT01856244

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2013

Typical duration for phase_1

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 17, 2013

Completed
15 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

October 5, 2016

Status Verified

October 1, 2016

Enrollment Period

3 years

First QC Date

May 8, 2013

Last Update Submit

October 4, 2016

Conditions

Parkinson's Disease

Keywords

Parkinson's Diseasetreadmill traininggaitbalancemobility

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline Gait Speed

    Self selected walking speed is assessed on a 10 meter walk distance

    8 weeks and 20 weeks

  • Change from Baseline Balance

    Mini - Balance Evaluation Systems Test (Mini - BESTest), Postural Sway in the Romberg Test with eyes open and eyes closed for 30 seconds

    8 weeks and 20 weeks

Secondary Outcomes (3)

  • Change from Baseline Gait Performance

    8 weeks and 20 weeks

  • Change from Baseline Mobility

    8 weeks and 20 weeks

  • Change from Baseline Unified Parkinson's Disease Rating Scale (UPDRS)

    8 weeks and 20 weeks

Study Arms (2)

sensorimotor treadmill training

EXPERIMENTAL

specific treadmill control using oscillating platform

Behavioral: treadmill walkingDevice: Treadmill

conventional treadmill training

ACTIVE COMPARATOR

conventional treadmill control

Behavioral: treadmill walkingDevice: Treadmill

Interventions

treadmill walkingBEHAVIORAL
conventional treadmill trainingsensorimotor treadmill training
TreadmillDEVICE
conventional treadmill trainingsensorimotor treadmill training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Erlangen, 91058, Germany

Location

Related Publications (2)

  • 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.

    PMID: 26655098BACKGROUND

  • 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.

    PMID: 27591395RESULT

MeSH Terms

Conditions

Parkinson Disease

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Klaus Pfeifer, Prof. Dr.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

May 8, 2013

First Posted

May 17, 2013

Study Start

June 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

October 5, 2016

Record last verified: 2016-10

Locations

DE(1)