Effects of Sensomotoric Insoles on Postural Control in Elderly People

Sponsor
Ludwig-Maximilians - University of Munich (Other)
Overall Status
Completed
CT.gov ID
NCT03120156
Collaborator
(none)
17
1
3
3.9
4.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: sensomotoric insoles
  • Device: normal standard insoles
  • Other: No insoles
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective randomized controlled trialProspective 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.
Primary Purpose:
Treatment
Official Title:
Effects of Sensomotoric Insoles on Postural Control in Elderly People - a Prospective Randomized Controlled Trial
Actual Study Start Date :
Jul 1, 2017
Actual Primary Completion Date :
Oct 27, 2017
Actual Study Completion Date :
Oct 27, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Posturographic measurement with Kistler's measuring plate [30 min.]

    a validated posturgraphy plate is measuring the balance ability

Secondary Outcome Measures

  1. Tinetti Balance and Gait instrument [15 min.]

    Well established tool for measuring balance ability of elderly people

  2. Functional reach test [5 min]

    Well established tool for measuring balance ability

  3. ABC-Scale [15 min]

    Questionnaire-Score for evaluation subjective feelings of unsure gait patterns or dizziness

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ludwig Maximilian University, University Hosipital, Department of Orthopedics, Physical Medicine and Rehabilitation Munich Germany 81377

Sponsors and Collaborators

  • Ludwig-Maximilians - University of Munich

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
PD Dr. Martin Weigl, MPH, Principal investigator, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT03120156
Other Study ID Numbers:
  • Senso-Insoles for Balance
First Posted:
Apr 19, 2017
Last Update Posted:
Nov 13, 2017
Last Verified:
Nov 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by PD Dr. Martin Weigl, MPH, Principal investigator, Ludwig-Maximilians - University of Munich
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 13, 2017