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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No insoles | Active Comparator | Control group of people with poor postural control that won't use insoles |
|
| Normal insoles | Active Comparator | Control group of people with poor postural control that will get normal standard insoles. |
|
| Sensomotoric insoles | Active Comparator | Control group of people with poor postural control that will get normal standard insoles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Posturographic measurement with Kistler's measuring plate | a validated posturgraphy plate is measuring the balance ability | 30 min. |
| 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 |
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ludwig Maximilian University, University Hosipital, Department of Orthopedics, Physical Medicine and Rehabilitation | Munich | 81377 | Germany |
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| ID | Term |
|---|---|
| D020233 | Gait Disorders, Neurologic |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Prospective randomized controlled trial
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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.
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| 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 |
|
| 5 min |
| ABC-Scale | Questionnaire-Score for evaluation subjective feelings of unsure gait patterns or dizziness | 15 min |