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Effects of Sensomotoric Insoles on Postural Control in Elderly People

L

Ludwig Maximilian University of Munich

Status

Completed

Conditions

Sensorimotor Gait Disorder

Treatments

Other: No insoles
Device: sensomotoric insoles
Device: normal standard insoles

Study type

Interventional

Funder types

Other

Identifiers

NCT03120156
Senso-Insoles for Balance

Details and patient eligibility

About

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.

Full 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.

Enrollment

17 patients

Sex

All

Ages

18 to 99 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

17 participants in 3 patient groups

No insoles
Active Comparator group
Description:
Control group of people with poor postural control that won't use insoles
Treatment:
Other: No insoles
Normal insoles
Active Comparator group
Description:
Control group of people with poor postural control that will get normal standard insoles.
Treatment:
Device: normal standard insoles
Sensomotoric insoles
Active Comparator group
Description:
Control group of people with poor postural control that will get normal standard insoles.
Treatment:
Device: sensomotoric insoles

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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