Clinical trial NCT04803565: The Effect of Personalized Shoe Insole on the Gait of Parkinson's Disease Subjects
Official title: The Effect of Personalized Shoe Insole on the Gait of Parkinson's Disease Subjects: A Triple-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Foot Orthoses
Randomized controlled trial
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to assess the efficacy of custom-made shoe insoles, for subjects with Parkinson's Disease (PD).

To do that, a sample of PD subjects has been randomly assigned to an intervention group that will receive the custom-made insoles or a control group that will receive a sham insole without any specific manufacturing.

Both groups will receive Physiotherapy and Occupational Therapy according to PD rehabilitation guidelines.

The principal outcome will be the Time Up\&Go test time, secondary outcomes 10 Meters Walking test speed, Berg Balance Scale score, SF12 score, and orthesis liking.


Eligibility criteria: Inclusion Criteria:

* Subjects with Idiopathic Parkinson's Disease;
* Age \> 18 years;
* Subjects should be in a positive therapeutic window or in the ON phase during the evaluations;
* Subjects must be able to walk at least 10 meters independently with or without any walking aid.

Exclusion Criteria:

* Not clinical stable subjects;
* SUbjects in OFF phase during the evaluations;
* Other neurological conditions (e.g. stroke, peripheral neuropathies, etc.);
* Other pathologies that can negatively influence the subject's walking ability (e.g. surgery at the lower limbs in the previous 6 months, important deformities at the lower limbs, etc.)

Primary outcomes:
measure: Change in Time Up&Go test
timeFrame: Baseline, at 10 weeks, and at 16 weeks.
Secondary outcomes:
measure: Change in 10 Meters walking test Speed
timeFrame: Baseline, at 10 weeks, and at 16 weeks.
measure: Change in Berg Balance Scale Score
timeFrame: Baseline, at 10 weeks, and at 16 weeks.
measure: Change in Short-Form12 score
timeFrame: Baseline, at 10 weeks, and at 16 weeks.
measure: Change in Likert scale 4 points
timeFrame: Baseline, at 10 weeks, and at 16 weeks.
measure: Change in 10 Meters Walking Test cadence
timeFrame: Baseline, at 10 weeks, and at 16 weeks.
measure: Change in 10 Meters Walking Test step length
timeFrame: Baseline, at 10 weeks, and at 16 weeks.
measure: Change in 10 Meters Walking Test step duration
timeFrame: Baseline, at 10 weeks, and at 16 weeks.
measure: Change in 10 Meters Walking Test stance phase
timeFrame: Baseline, at 10 weeks, and at 16 weeks.
measure: Change in 10 Meters Walking Test swing phase
timeFrame: Baseline, at 10 weeks, and at 16 weeks.
measure: Change in 10 Meters Walking Test single support phase
timeFrame: Baseline, at 10 weeks, and at 16 weeks.
measure: Change in 10 Meters Walking Test double support phase
timeFrame: Baseline, at 10 weeks, and at 16 weeks.
measure: Change in Time Up&Go test sit-to-stand time
timeFrame: Baseline, at 10 weeks, and at 16 weeks.
measure: Change in Time Up&Go test stand-to-sit time
timeFrame: Baseline, at 10 weeks, and at 16 weeks.
measure: Change in Time Up&Go test mid-turning time
timeFrame: Baseline, at 10 weeks, and at 16 weeks.
measure: Change in Time Up&Go test end-turning time
timeFrame: Baseline, at 10 weeks, and at 16 weeks.
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Fondazione Don Carlo Gnocchi
Study officials:
References: