Effects of Sensomotoric Insoles on Postural Control in Elderly People

Not Applicable

Completed

• Conditions: Sensorimotor Gait Disorder
• Interventions: Other: No insoles; Device: sensomotoric insoles; Device: normal standard insoles

• Registration Number: NCT03120156
• Lead Sponsor: Ludwig-Maximilians - University of Munich

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-03-30
• Study First Submitted QC: 2017-04-18
• Study First Posted: 2017-04-19
• Study Start: 2017-07-01
• Primary Completion: 2017-10-27
• Study Completion: 2017-10-27
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-09
• Last Update Posted: 2017-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No insoles	No insoles	Control group of people with poor postural control that won't use insoles
Sensomotoric insoles	sensomotoric insoles	Control group of people with poor postural control that will get normal standard insoles.
Normal insoles	normal standard insoles	Control group of people with poor postural control that will get normal standard insoles.

Primary Outcome Measures

Name	Time	Method
Posturographic measurement with Kistler's measuring plate	30 min.	a validated posturgraphy plate is measuring the balance ability

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ludwig Maximilian University, University Hosipital, Department of Orthopedics, Physical Medicine and Rehabilitation; 🇩🇪 Munich, Germany