Effects of Sensomotoric Insoles on Postural Control in Elderly People

Sensorimotor Gait Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03120156
• Other study ID #: Senso-Insoles for Balance
• Status: Completed
• Phase: N/A
• First received: March 30, 2017
• Last updated: November 9, 2017
• Start date: July 1, 2017
• Est. completion date: October 27, 2017

Study information

• Verified date: November 2017
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 27, 2017
• Est. primary completion date: October 27, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Sensorimotor Gait Disorder

Intervention

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.
• normal standard insoles
Normal standard insole like you will get them by receipe from an orthotic shop

Other:
• No insoles
control group with no insoles in the shoes

Locations

Country	Name	City	State
Germany	Ludwig Maximilian University, University Hosipital, Department of Orthopedics, Physical Medicine and Rehabilitation	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Posturographic measurement with Kistler's measuring plate	a validated posturgraphy plate is measuring the balance ability	30 min.
Secondary	Tinetti Balance and Gait instrument	Well established tool for measuring balance ability of elderly people	15 min.
Secondary	Functional reach test	Well established tool for measuring balance ability	5 min
Secondary	ABC-Scale	Questionnaire-Score for evaluation subjective feelings of unsure gait patterns or dizziness	15 min