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Effects of Sensomotoric Insoles on Postural Control in Elderly People

NCT ID: NCT03120156

Last Updated: 2017-11-13

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

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2017-10-27

Brief Summary

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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

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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.

Conditions

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Sensorimotor Gait Disorder

Keywords

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sensomotoric insoles postural control proprioceptive insoles insoles

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Sensomotoric insoles and normal insoles or no insoles are not maskable.Patients and all involved persons will be able to easily see which type of insoles are used.

No blinding possible.

Study Groups

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No insoles

Control group of people with poor postural control that won't use insoles

Group Type ACTIVE_COMPARATOR

No insoles

Intervention Type OTHER

control group with no insoles in the shoes

Normal insoles

Control group of people with poor postural control that will get normal standard insoles.

Group Type ACTIVE_COMPARATOR

normal standard insoles

Intervention Type DEVICE

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

Sensomotoric insoles

Control group of people with poor postural control that will get normal standard insoles.

Group Type ACTIVE_COMPARATOR

sensomotoric insoles

Intervention Type 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.

Interventions

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sensomotoric insoles

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.

Intervention Type DEVICE

normal standard insoles

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

Intervention Type DEVICE

No insoles

control group with no insoles in the shoes

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role lead

Responsible Party

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PD Dr. Martin Weigl, MPH

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Munich, , Germany

Site Status

Countries

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Germany

Other Identifiers

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Senso-Insoles for Balance

Identifier Type: -

Identifier Source: org_study_id