Effects of Sensomotoric Insoles on Postural Control in Elderly People

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

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.

Study Overview

• Status: Completed
• Conditions: Sensorimotor Gait Disorder
• Intervention / Treatment: Other: No insoles; Device: normal standard insoles; Device: sensomotoric insoles

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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany, 81377
    • Ludwig Maximilian University, University Hosipital, Department of Orthopedics, Physical Medicine and Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): October 27, 2017
• Study Completion (Actual): October 27, 2017

Study Registration Dates

• First Submitted: March 30, 2017
• First Submitted That Met QC Criteria: April 18, 2017
• First Posted (Actual): April 19, 2017

Study Record Updates

• Last Update Posted (Actual): November 13, 2017
• Last Update Submitted That Met QC Criteria: November 9, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: postural control; insoles; sensomotoric insoles; proprioceptive insoles
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Gait Disorders, Neurologic
• Other Study ID Numbers: Senso-Insoles for Balance

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No