Effects of Sensomotoric Insoles on Postural Control in Elderly People

NCT03120156 | Completed

• 1 other identifier: Senso-Insoles for Balance
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Sensorimotor Gait Disorder

Keywords

sensomotoric insoles; postural control; proprioceptive insoles; insoles

Outcome Measures

Primary Outcomes (1)

• Posturographic measurement with Kistler's measuring plate

  a validated posturgraphy plate is measuring the balance ability

  30 min.

Secondary Outcomes (3)

• Tinetti Balance and Gait instrument

  15 min.

• Functional reach test

  5 min

• ABC-Scale

  15 min

Study Arms (3)

No insoles

ACTIVE COMPARATOR

Control group of people with poor postural control that won't use insoles

Other: No insoles

Normal insoles

ACTIVE COMPARATOR

Control group of people with poor postural control that will get normal standard insoles.

Device: normal standard insoles

Sensomotoric insoles

ACTIVE COMPARATOR

Control group of people with poor postural control that will get normal standard insoles.

Device: sensomotoric insoles

Interventions

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.

Sensomotoric insoles

normal standard insoles DEVICE

Normal standard insole like you will get them by receipe from an orthotic shop

Normal insoles

No insoles OTHER

control group with no insoles in the shoes

No insoles

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ABC-Scale \< 70% Functional reach test \< 30cm Subjective feeling of unsure gait or several falls in the last 5 years

You may not qualify if:

• Structural pathologies in the balance system Neuropathologies like Polyneuropathy

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (1)

Ludwig Maximilian University, University Hosipital, Department of Orthopedics, Physical Medicine and Rehabilitation

Munich, 81377, Germany

Location

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Prospective randomized controlled trial

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 19, 2017
• Study Start: July 1, 2017
• Primary Completion: October 27, 2017
• Study Completion: October 27, 2017
• Last Updated: November 13, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)