Effects of Sensomotoric Insoles on Postural Control in Elderly People

Study Overview
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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.

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

Conditions
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Sensorimotor Gait Disorder

Intervention / Treatment
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* Device: sensomotoric insoles
* Device: normal standard insoles
* Other: No insoles


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: No insoles<br>Control group of people with poor postural control that won't use insoles | Other: No insoles<br>* control group with no insoles in the shoes<br>|
| Active Comparator: Normal insoles<br>Control group of people with poor postural control that will get normal standard insoles. | Device: normal standard insoles<br>* Normal standard insole like you will get them by receipe from an orthotic shop<br>|
| Active Comparator: Sensomotoric insoles<br>Control group of people with poor postural control that will get normal standard insoles. | Device: sensomotoric insoles<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posturographic measurement with Kistler's measuring plate | a validated posturgraphy plate is measuring the balance ability | 30 min. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinetti Balance and Gait instrument | Well established tool for measuring balance ability of elderly people | 15 min. | 
| Functional reach test | Well established tool for measuring balance ability | 5 min | 
| ABC-Scale | Questionnaire-Score for evaluation subjective feelings of unsure gait patterns or dizziness | 15 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insoles, sensomotoric insoles, postural control, proprioceptive insoles