Back to resultsEffects of Sensomotoric Insoles on Postural Control in Elderly People
Primary Purpose
Sensorimotor Gait Disorder
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
sensomotoric insoles
normal standard insoles
No insoles
Sponsored by
About this trial
This is an interventional treatment trial for Sensorimotor Gait Disorder focused on measuring sensomotoric insoles, postural control, proprioceptive insoles, insoles
Eligibility Criteria
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
Sites / Locations
- Ludwig Maximilian University, University Hosipital, Department of Orthopedics, Physical Medicine and Rehabilitation
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
No insoles
Normal insoles
Sensomotoric insoles
Arm Description
Control group of people with poor postural control that won't use insoles
Control group of people with poor postural control that will get normal standard insoles.
Control group of people with poor postural control that will get normal standard insoles.
Outcomes
Primary Outcome Measures
Posturographic measurement with Kistler's measuring plate
a validated posturgraphy plate is measuring the balance ability
Secondary Outcome Measures
Tinetti Balance and Gait instrument
Well established tool for measuring balance ability of elderly people
Functional reach test
Well established tool for measuring balance ability
ABC-Scale
Questionnaire-Score for evaluation subjective feelings of unsure gait patterns or dizziness
Full Information
NCT ID
NCT03120156
First Posted
March 30, 2017
Last Updated
November 9, 2017
Sponsor
Ludwig-Maximilians - University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT03120156
Brief Title
Effects of Sensomotoric Insoles on Postural Control in Elderly People
Official Title
Effects of Sensomotoric Insoles on Postural Control in Elderly People - a Prospective Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
October 27, 2017 (Actual)
Study Completion Date
October 27, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ludwig-Maximilians - University of Munich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensorimotor Gait Disorder
Keywords
sensomotoric insoles, postural control, proprioceptive insoles, insoles
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized controlled trial
Masking
None (Open Label)
Masking Description
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.
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No insoles
Arm Type
Active Comparator
Arm Description
Control group of people with poor postural control that won't use insoles
Arm Title
Normal insoles
Arm Type
Active Comparator
Arm Description
Control group of people with poor postural control that will get normal standard insoles.
Arm Title
Sensomotoric insoles
Arm Type
Active Comparator
Arm Description
Control group of people with poor postural control that will get normal standard insoles.
Intervention Type
Device
Intervention Name(s)
sensomotoric insoles
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
normal standard insoles
Intervention Description
Normal standard insole like you will get them by receipe from an orthotic shop
Intervention Type
Other
Intervention Name(s)
No insoles
Intervention Description
control group with no insoles in the shoes
Primary Outcome Measure Information:
Title
Posturographic measurement with Kistler's measuring plate
Description
a validated posturgraphy plate is measuring the balance ability
Time Frame
30 min.
Secondary Outcome Measure Information:
Title
Tinetti Balance and Gait instrument
Description
Well established tool for measuring balance ability of elderly people
Time Frame
15 min.
Title
Functional reach test
Description
Well established tool for measuring balance ability
Time Frame
5 min
Title
ABC-Scale
Description
Questionnaire-Score for evaluation subjective feelings of unsure gait patterns or dizziness
Time Frame
15 min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Ludwig Maximilian University, University Hosipital, Department of Orthopedics, Physical Medicine and Rehabilitation
City
Munich
ZIP/Postal Code
81377
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Sensomotoric Insoles on Postural Control in Elderly People
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