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CompletedNCT05899426Updated Sep 19, 2024

Motor Learning-based Clinical Pilates Rehabilitation Protocol for Patients with Parkinson's Disease

An interventional study of motor learning based clinical pilates and Conventional Physiotherapy in Parkinson Disease, sponsored by European University of Lefke. Completed at 1 site in Turkey. Open to participants aged 45 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by European University of Lefke · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
45 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

The patients with Parkinson's Disease will be randomly assigned into two groups: Motor Learning based Clinical Pilates (MLCP) Group and Conventional Physiotherapy (CP) Group. Both groups will be treated for 12 weeks. The evaluation of the patients will be done before the beginning of exercise program, midterm evaluation in the 6th week and will be repeated at the end. Also there will be followed up evaluation with the same assessments at the 3rd month. Physical function/motor function of patients will be evaluated with The Unified Parkinson's Disease Rating Scale (UPDRS) III subscale, dynamic balance with Functional Reach Test (FRT), postural control and dynamic balance will also be evaluated with Berg Balance Scale and functional mobility by Timed Up and Go Test. Gait, balance and functional domains of the patients will be evaluated with Gait and Balance Scale (GABS), Nelson foot reaction test will be used for the reaction time.

02

Conditions studied

  • Parkinson Disease

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Keywords

  • Parkinson Disease
  • Exercise
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 32 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

European University of Lefke is the lead sponsor of 22 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Serious mental and psychological disorder
  • Significant musculoskeletal disorders
  • Lower extremity deformation
  • Having another neurological disease
  • Drug or dose change during treatment
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Motor learning based clinical pilates

    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

  • Active comparator
    Conventional Physiotherapy

    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

  • Othermotor learning based clinical pilates

    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

  • OtherConventional Physiotherapy

    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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 5 minutes

  2. 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).

    Time frame: 15 minutes

  3. 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.

    Time frame: 2 minutes

Secondary outcomes

  1. Functional reach test

    A balance test designed to measure stability limits. The patient is asked to raise the dominant arm 90 ° and place it at the shoulder level and extend as far as it can go forward, without loss of movement or balance in the feet. Reduced ability to reach indicates an increased risk of falling in the future.

    Time frame: 5 minutes

  2. Timed-up and Go test

    When the command is given, the patient gets up from a normal chair, walks 3 meters, turns and walks back to the chair and sits down. The time starts when the command is given and ends when the person sits back in the chair.

    Time frame: 5 minutes

  3. Berg Balance Scale

    This test is used to measure a person\&amp;amp;amp;amp;amp;#39;s static and dynamic balance performance. It is effective in assessing postural control and predicting the risk of falling. It is a 14-item test that uses 0 to 4 sequential scoring for each item. The total score range is from 0 to 56 and a higher score indicates a better balance.

    Time frame: 15 minutes

  4. The Unified Parkinson&amp;amp;amp;amp;amp;#39;s Disease Rating Scale (UPDRS) III. Subscale

    The severity of motor symptoms will be assessed with the UPDRS III. (1) bradykinesia (finger taps, hand movements, rapid alternating movements of hand, leg agility, body bradykinesia and hypokinesia); (2) rigidity; (3) tremor (tremor at rest, action or postural tremor of hands); and (4) axial symptoms (arising from chair, posture, gait, postural stability).

    Time frame: 15 minutes

07

Study locations

1 site
  • European University of Lefke
    Mersin, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05899426
Lead sponsor
European University of Lefke
Responsible party
Sponsor
First posted
Jun 12, 2023
Start date
Jun 25, 2023
Primary completion
Mar 20, 2024
Completion
Jun 15, 2024
Last update
Sep 19, 2024

Study contacts

Beliz Belgen Kaygısız, PT, PhD
principal investigator · European University of Lefke
Fahriye Çoban, PT, MSc
principal investigator · European University of Lefke

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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