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Clinical Trials/NCT03120156
NCT03120156
Completed
Not Applicable

Effects of Sensomotoric Insoles on Postural Control in Elderly People - a Prospective Randomized Controlled Trial

Ludwig-Maximilians - University of Munich1 site in 1 country17 target enrollmentJuly 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sensorimotor Gait Disorder
Sponsor
Ludwig-Maximilians - University of Munich
Enrollment
17
Locations
1
Primary Endpoint
Posturographic measurement with Kistler's measuring plate
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

People with weak balance ability or subjective feeling of dizziness and unsure gait are separated into 3 training-groups. One Group is getting no insoles, the second group is getting modern sensomotoric insoles, and the third group is getting normal standard insoles. All are passing a 6 week proprioceptive training.

Main outcome measurements are posturography at baseline, 3 weeks and 6 weeks. Secondary measurements are ABC-Scale, Tinetti Gait and balance test and functional reach test at baseline and after 6 weeks.

Detailed Description

People with weak balance ability or subjective feeling of dizziness and unsure gait are separated into 3 training-groups. Exclusion criteria are structural neuropathic cause for dizziness, severe ocular deficience, cochlear causes for dizziness. The 3 Groups differ in following criteria: Group 1: Gets basic insoles after 3-D-Scan of the foot Group 2: Gets sensomotoric insoles (Jahrling) after 3-D-Scan of the foot. Group 3: Control-Group = no insoles Alle groups are doing a 6 weeks proprioceptive training 2 times a week for 45min. Balance-Ability is measured by a posturographic plate prior to the training, after 3 weeks training and after 6 weeks of training. ABC-Score, Tinetti Gait and Balance test and functional reach test are secondary outcome measurements and are evaluated prior the training and after 6 weeks of training.

Registry
clinicaltrials.gov
Start Date
July 1, 2017
End Date
October 27, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

PD Dr. Martin Weigl, MPH

Principal investigator

Ludwig-Maximilians - University of Munich

Eligibility Criteria

Inclusion Criteria

  • ABC-Scale \< 70% Functional reach test \< 30cm Subjective feeling of unsure gait or several falls in the last 5 years

Exclusion Criteria

  • Structural pathologies in the balance system Neuropathologies like Polyneuropathy

Outcomes

Primary Outcomes

Posturographic measurement with Kistler's measuring plate

Time Frame: 30 min.

a validated posturgraphy plate is measuring the balance ability

Secondary Outcomes

  • Tinetti Balance and Gait instrument(15 min.)
  • Functional reach test(5 min)
  • ABC-Scale(15 min)

Study Sites (1)

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