Sensorimotor Gait DisorderNCT03120156
Effects of Sensomotoric Insoles on Postural Control in Elderly People
A study testing sensomotoric insoles, normal standard insoles and No insoles in people with Sensorimotor Gait Disorder, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Sensorimotor Gait Disorder
- What is being tested?
- sensomotoric insoles, normal standard insoles and No insoles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2017to 27 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ABC-Scale < 70% Functional reach test < 30cm Subjective feeling of unsure gait or several falls in the last 5 years
Who cannot join
- Structural pathologies in the balance system Neuropathologies like Polyneuropathy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Ludwig Maximilian University, University Hosipital, Department of Orthopedics, Physical Medicine and Rehabilitation
Munich, 81377
About this study
Official title: Effects of Sensomotoric Insoles on Postural Control in Elderly People - a Prospective Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Sensorimotor Gait Disorder
- Being tested
- sensomotoric insoles, normal standard insoles, No insoles
- Keywords
- sensomotoric insoles, postural control, proprioceptive insoles, insoles
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sensomotoric insolesDevice
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 insolesDevice
Normal standard insole like you will get them by receipe from an orthotic shop
No insolesOther
control group with no insoles in the shoes
| Study group | Role | What they receive |
|---|---|---|
| No insoles | Active comparator | Control group of people with poor postural control that won't use insoles Receives: Other: No insoles |
| Normal insoles | Active comparator | Control group of people with poor postural control that will get normal standard insoles. Receives: Device: normal standard insoles |
| Sensomotoric insoles | Active comparator | Control group of people with poor postural control that will get normal standard insoles. Receives: Device: sensomotoric insoles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posturographic measurement with Kistler's measuring plate
a validated posturgraphy plate is measuring the balance ability
Measured: 30 min.
Secondary outcomes (3)
Tinetti Balance and Gait instrument
Well established tool for measuring balance ability of elderly people
Measured: 15 min.
Functional reach test
Well established tool for measuring balance ability
Measured: 5 min
ABC-Scale
Questionnaire-Score for evaluation subjective feelings of unsure gait patterns or dizziness
Measured: 15 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start1 Jul 2017
- Primary completion27 Oct 2017
- Study completion27 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensorimotor Gait DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. Martin Weigl, MPH, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120156
- Sponsor's protocol ID
- Senso-Insoles for Balance
- Status last verified
- Nov 2017
- First submitted
- 30 Mar 2017
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sensomotoric Insoles on Postural Control in Elderly People - a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03120156
- Acronym / sponsor ID
- Senso-Insoles for Balance
- Conditions
- Sensorimotor Gait Disorder
- Keywords
- sensomotoric insoles, postural control, proprioceptive insoles, insoles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 27 Oct 2017 (actual)
- Study completion
- 27 Oct 2017 (actual)
- First posted
- 19 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Prospective randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| No insoles | Active comparator | Other: No insolesControl group of people with poor postural control that won't use insoles |
| Normal insoles | Active comparator | Device: normal standard insolesControl group of people with poor postural control that will get normal standard insoles. |
| Sensomotoric insoles | Active comparator | Device: sensomotoric insolesControl group of people with poor postural control that will get normal standard insoles. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ABC-Scale < 70% Functional reach test < 30cm Subjective feeling of unsure gait or several falls in the last 5 years
Key exclusion criteria (1 listed)
- Structural pathologies in the balance system Neuropathologies like Polyneuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sensomotoric insolessensomotoric 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. | Device | Sensomotoric insoles |
| normal standard insolesNormal standard insole like you will get them by receipe from an orthotic shop | Device | Normal insoles |
| No insolescontrol group with no insoles in the shoes | Other | No insoles |
Primary outcome
Posturographic measurement with Kistler's measuring plate
Time frame: 30 min.
a validated posturgraphy plate is measuring the balance ability
3 secondary outcomes
Tinetti Balance and Gait instrument
Time frame: 15 min.
Functional reach test
Time frame: 5 min
ABC-Scale
Time frame: 15 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sensomotoric insoles, normal standard insoles and No insoles in people with Sensorimotor Gait Disorder, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posturographic measurement with Kistler's measuring plate (time frame: 30 min.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2017.