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Stability and Balance in Locomotion Through Exercise (StaBLE)

U

University of Erlangen-Nürnberg

Status and phase

Completed
Phase 1

Conditions

Parkinson's Disease

Treatments

Behavioral: treadmill walking
Device: Treadmill

Study type

Interventional

Funder types

Other

Identifiers

NCT01856244
DSN-0613

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

48 participants in 2 patient groups

sensorimotor treadmill training
Experimental group
Description:
specific treadmill control using oscillating platform
Treatment:
Device: Treadmill
Behavioral: treadmill walking
conventional treadmill training
Active Comparator group
Description:
conventional treadmill control
Treatment:
Device: Treadmill
Behavioral: treadmill walking

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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