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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03120156
Enrollment
17
Registered
2017-04-19
Start date
2017-07-01
Completion date
2017-10-27
Last updated
2017-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sensorimotor Gait Disorder

Keywords

sensomotoric insoles, postural control, proprioceptive insoles, insoles

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.

Interventions

DEVICEsensomotoric 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.

DEVICEnormal standard insoles

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

OTHERNo insoles

control group with no insoles in the shoes

Sponsors

Ludwig-Maximilians - University of Munich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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.

Intervention model description

Prospective randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Posturographic measurement with Kistler's measuring plate30 min.a validated posturgraphy plate is measuring the balance ability

Secondary

MeasureTime frameDescription
Tinetti Balance and Gait instrument15 min.Well established tool for measuring balance ability of elderly people
Functional reach test5 minWell established tool for measuring balance ability
ABC-Scale15 minQuestionnaire-Score for evaluation subjective feelings of unsure gait patterns or dizziness

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026