NCT05899426

Brief Summary

Individuals with Parkinson's disease demonstrate impaired motor learning, including a slower acquisition rate and poor retention, which may result from deficits in cognitive function, especially executive function. Considering the reduced motor learning ability in this patient group, exercises should be designed with a focus on strengthening sensory inputs and basic functional training. Therefore, the investigators established this program according to previous experience published study \[NCT04063605\]. Therefore, the feasibility of this rehabilitation protocol, which combines motor learning and clinical pilates principles and is adapted to the needs of individuals with Parkinson's disease, will be examined.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

June 25, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
Last Updated

September 19, 2024

Status Verified

August 1, 2024

Enrollment Period

9 months

First QC Date

May 28, 2023

Last Update Submit

September 17, 2024

Conditions

Keywords

Parkinson DiseaseExercise

Outcome Measures

Primary Outcomes (3)

  • Nelson Foot Reaction Test

    This test is measured using a ruler and this gives the simple reaction time. The participant sits against the wall with the toe at a distance of 2.5 cm and the heel at a distance of 5 cm from the wall. The test administrator holds the reaction ruler between the wall and the participant's foot and releases the ruler as soon as the participant is ready. The participant tries to hold the falling ruler by squeezing it against the wall. It will be measured 20 times. Five best and five worst values will be discarded and the average of the remaining measurement will be taken.

    5 minutes

  • Gait and Balance Scale (Untimed Tasks)

    Gait and Balance Scale (GABS) consists of historical information and examination of 14 different gait and balance parameters designed to assess the severity of these functional domains. Thirty-five patients with Parkinson's disease (PD), Hoehn and Yahr stages 1 - 3, were tested. Items 1 to 17 GABS are scored on a scale of 0 to 4 (0 being normal and 4 being the worst). Items 18- 24 are scored on a scale 0 to 1 or 0 to 2 (0 being normal and 1 or 2 being abnormal).

    15 minutes

  • Gait and Balance Scale (Timed Tasks - Cadence)

    Gait and Balance Scale (GABS) consists of timed tasks to assess gait speed and the 'up-and-go' test. Timed tasks provide valuable information about the gait cycle by measuring speed of walking, variation between the normal and fast gait speed, stand-walk-sit time and cadence.

    2 minutes

Secondary Outcomes (4)

  • Functional reach test

    5 minutes

  • Timed-up and Go test

    5 minutes

  • Berg Balance Scale

    15 minutes

  • The Unified Parkinson's Disease Rating Scale (UPDRS) III. Subscale

    15 minutes

Study Arms (2)

Motor learning based clinical pilates

EXPERIMENTAL

Participants in this group will receive training for 60 minutes 2 times a week for 12 weeks and will be followed up with the same assessments at the 3rd months after the treatment.

Other: motor learning based clinical pilates

Conventional Physiotherapy

ACTIVE COMPARATOR

Participants in this group will receive training for 60 minutes 2 times a week for 12 weeks and will be followed up with the same assessments at the 3rd months after the treatment.

Other: Conventional Physiotherapy

Interventions

The exercises will be created as function and goal. At least one stimulus will be given during each exercise (visual, tactile, auditory or vestibular). 2 different levels were determined for 3 months of treatment, according to the months. As the level increased, the intensity of the exercise increased. In general, the exercise intensity was increased according to the against gravity and the decreasing in the support area.

Also known as: Parkinsonpilates
Motor learning based clinical pilates

This exercise program will include strengthening, stretching, posture exercises, balance and gait exercises. Aim is to improve muscle strength and prevent shortness of muscles. Also, balance and gait exercise aim to improve walking capacity.

Also known as: Control group
Conventional Physiotherapy

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having modified Hoehn \& Yahr Scale grade 2-3 symptoms
  • Be over 45 years old
  • Having a score of 24 or 24\< on the Mini Mental test
  • To be able to read and write in Turkish
  • Having at least 2 years Parkinson's Disease

You may not qualify if:

  • Serious mental and psychological disorder
  • Significant musculoskeletal disorders
  • Lower extremity deformation
  • Having another neurological disease
  • Drug or dose change during treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European University of Lefke

Mersin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson DiseaseMotor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Beliz Belgen Kaygısız, PT, PhD

    European University of Lefke

    PRINCIPAL INVESTIGATOR
  • Fahriye Çoban, PT, MSc

    European University of Lefke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 groups will receive different exercise program for 12 weeks.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2023

First Posted

June 12, 2023

Study Start

June 25, 2023

Primary Completion

March 20, 2024

Study Completion

June 15, 2024

Last Updated

September 19, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations