Effects of Exercise With Visual Feedback in Parkinson's Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorHasan Kalyoncu University
About this trial
Patients with Parkinson's disease who apply to the Hasan Kalyoncu University Application and Research Center and meet the inclusion criteria will be included in the study. The included participants will be randomly assigned into either the intervention group or the control group using a sealed-envelope method. Both groups will undergo a standard exercise program, consisting of posture, strengthening, and balance training, under the supervision of a physiotherapist for 8 weeks, 3 days per week. In addition to this, the intervention group will receive an additional exercise program incorporating visual feedback using a laser pointer, targeting the trunk and lower extremities, also under the supervision of a physiotherapist for 8 weeks, 3 days per week.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals diagnosed with idiopathic Parkinson's disease
Disease severity classified as stage 1 to 3 according to the Modified Hoehn and Yahr Scale
Patients receiving oral antiparkinsonian treatment only
Presence of musculoskeletal, cardiovascular, or vestibular disorders that may interfere with the completion of the assessments or treatment protocol
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Control Group
Other interventionThe exercises will start with 6-8 repetitions and will increase by 2 repetitions each week. Cervical Region: Cervical rotation, lateral flexion, chin-tuck exercises Upper Extremity: Shoulder joint range of motion exercises with a wand, scapular adduction, shoulder retraction Lower Extremity: Bridge exercise, hip flexion, extension, abduction exercises, knee extension exercises, ankle dorsiflexion - plantar flexion exercises Balance Exercises: Perturbation exercises with eyes open and eyes closed on a hard surface, perturbation exercises with eyes open and eyes closed on a soft surface, maintaining a tandem stance Ambulation: Walking training on a treadmill with a Modified Borg Scale of level 3-4. Walking training will begin with 6 minutes in the first week and will increase by 1 minute each week.
Visual Feedback Exercise Group
Other interventionThe visual feedback exercise will be performed using a wearable laser pointer attached to the trunk and lower extremities, along with a visual tracking screen. The exercise duration is 20 minutes. The laser placed on the trunk will be used in various exercises, including maintaining stability in a seated position, on a Swiss ball, while standing, during different movements, and on various surfaces. Additionally, trunk control exercises will involve rotational, vertical-horizontal, and circular movements. Exercises targeting trunk control in a crawling position will also be included. For the lower extremities, the program will focus on ankle dorsiflexion, hip abduction and extension, and knee extension. All exercises will be progressively individualized on a weekly basis.
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: standard exercise programActive comparator 1 intervention
Group B: standard exercise program and visual feedback-based exercise programExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Center of Pressure Elliptical Area
Postural control will be assessed using the Gyko wearable device. After the wearable vest is properly fitted, the participant will be asked to maintain balance for 30 seconds under four conditions: firm surface with eyes open, firm surface with eyes closed, soft surface with eyes open, and soft surface with eyes closed. The elliptical area of center of pressure displacement (mm²) obtained from the Gyko system will be recorded for each condition and used as the primary outcome measure.
Time frame
up to 8 weeks2
Berg Balance Scale
The Berg Balance Scale is used to assess functional balance. It evaluates both dynamic and static balance through 14 tasks related to different positions, postural changes, and mobility. Each task is scored between 0 and 4 based on the individual's ability to perform the task independently, for a certain period, or over a specific distance (0: unable to perform, 4: normal performance). The highest possible score on the scale is 56, and a higher score indicates greater independence.
Time frame
up to 8 weeksSecondary outcomes
1
L Test
The L Test is a functional mobility assessment. The participant starts from a seated position in a chair without armrests and, upon command, walks at a comfortable speed to a marked 3-meter point, turns right, continues walking for 7 meters, turns around, and returns to sit in the chair. The total time to complete the test (seconds) will be recorded.
Time frame
up to 8 weeks2
Unified Parkinson's Disease Rating Scale
The first section evaluates non-motor features, the second section assesses activities of daily living, the third section involves motor examination, and the fourth section evaluates treatment complications. The four sections total 42 items. Each item is scored from 0 (no symptoms or signs) to 4 (the most severe symptoms or signs).
Time frame
up to 8 weeks3
New York Postural Assessment Test
For each of the 13 body segments, three diagrams are provided. The posterior view includes the head, shoulders, spine, hips, and feet, while the lateral view includes the neck, chest, shoulders, upper back, trunk, abdomen, and lumbar region. Each body segment is scored as follows: 5 points (correct posture), 3 points (moderate deviation), and 1 point (severe deviation). The total score ranges from 13 to 65. A higher score indicates better posture.
Time frame
up to 8 weeks4
Visual Analog Scale
Pain intensity was assessed using the Visual Analog Scale (VAS), which consists of a 100-mm horizontal line with scores ranging from 0 to 100 mm. Participants were instructed to mark the point on the line that best represented their current pain intensity, where 0 indicated "no pain" and 100 indicated "worst imaginable pain." The distance in millimeters from the left end of the line to the marked point was measured using a ruler. Higher VAS scores indicate greater pain intensity.
Time frame
up to 8 weeksSponsors and contacts
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Source ClinicalTrials.gov