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Completed

NCT Number: NCT03120156

Effects of Sensomotoric Insoles on Postural Control in Elderly People

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.

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Key information

Conditions

Sensorimotor Gait Disorder Gait Disorders, Neurologic Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ludwig Maximilian University, University Hosipital, Department of Orthopedics, Physical Medicine and Rehabilitation

Munich, 81377, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sensomotoric insoles

Device

sensomotoric insoles were published by Jahrling (2007) and have a certain shape that could improve balance abilities. The toes 2-4 are higher that toe 1, so that the tendons of the toe-flectors are pre-stressed.

normal standard insoles

Device

Normal standard insole like you will get them by receipe from an orthotic shop

No insoles

Other

control group with no insoles in the shoes

Primary outcomes

  1. Posturographic measurement with Kistler's measuring plate

    Time frame: 30 min.

    a validated posturgraphy plate is measuring the balance ability

Secondary outcomes

  1. Tinetti Balance and Gait instrument

    Time frame: 15 min.

    Well established tool for measuring balance ability of elderly people

  2. Functional reach test

    Time frame: 5 min

    Well established tool for measuring balance ability

  3. ABC-Scale

    Time frame: 15 min

    Questionnaire-Score for evaluation subjective feelings of unsure gait patterns or dizziness

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 19, 2017
Registry last updated
Nov 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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