Home-Based Exercise Programs for Fall Prevention in Parkinson Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorUludag University
About this trial
Falls are common in patients with Parkinson disease and may lead to reduced mobility, fear of falling, loss of independence, and injury. Exercise-based rehabilitation programs may help improve balance, gait, and physical performance in this population.
This randomized controlled trial aims to compare the effectiveness of two home-based exercise programs in patients with Parkinson disease: the Otago Exercise Program and a structured home exercise program. Participants will be randomly assigned to one of two groups. Both groups will receive exercise education and will perform their assigned home exercise program for 6 weeks.
Participants will be evaluated at baseline, at week 3, and at the end of week 6. The study will assess fall-related outcomes, freezing of gait, functional mobility, gait parameters, postural control, and physical performance. The results may help determine which home-based exercise approach is more effective for reducing fall risk and improving functional outcomes in patients with Parkinson disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of Parkinson disease confirmed by a neurologist
Hoehn and Yahr stage 3 or 4 Parkinson disease
Diagnosis of Parkinson disease for at least 5 years
Willingness to participate in the study and provide written informed consent
Disqualifiers
Balance or gait impairment due to causes other than Parkinson disease, such as severe orthopedic problems or another neurological disease
Red flags suggestive of Parkinson-plus syndromes, such as symmetric onset, early falls, early-onset dementia, or gaze palsy
History of serious fall-related injury or surgery within the last 6 months
Any additional health condition that would prevent participation in the exercise program during the study period
Trial design
Design model
Parallel
Treatments tested in this trial
Otago Home Exercise Program
Behavioralnce exercises designed to improve lower extremity muscle strength, balance, functional mobility, and fall-related outcomes. Participants will perform the program 3 times per week for 6 weeks, with each session lasting approximately 40 minutes. The program will be reviewed and progressed at week 3.
Structured Home Exercise Program
BehavioralThe structured home exercise program is a home-based exercise intervention including spinal stabilization exercises and stretching and strengthening exercises targeting the ankle plantar flexor and dorsiflexor muscles, quadriceps, lumbar extensor muscles, pectoral muscles, and hamstring muscles. Participants will perform the program 3 times per week for 6 weeks, with each session lasting approximately 40 minutes. The program will be reviewed and progressed at week 3.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Otago Home Exercise ProgramExperimental treatment 1 intervention
Group B: Structured Home Exercise ProgramActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Falls Efficacy Scale
Fall-related self-efficacy and fear of falling will be assessed using the Falls Efficacy Scale. The scale evaluates the participant's confidence in performing daily activities without falling. Scores range from 10 to 100, with lower scores indicating greater fear of falling and higher scores indicating lower fear of falling.
Time frame
Baseline, week 3, and week 6Secondary outcomes
1
Freezing of Gait Questionnaire (FOGQ)
Freezing of gait will be assessed using the Freezing of Gait Questionnaire (FOGQ). The FOGQ evaluates the severity of freezing episodes and their impact on walking performance in patients with Parkinson disease. The total score ranges from 0 to 24. Higher scores indicate more severe freezing of gait and worse walking performance.
Time frame
Baseline, week 3, and week 62
Gait Speed
Gait speed will be assessed using video-based kinematic analysis with Kinovea software. Walking speed will be calculated in meters per second from recorded walking trials. Higher gait speed indicates better walking performance.
Time frame
Baseline, week 3, and week 63
Timed Up and Go Test
r, walk a short distance, turn, walk back, and sit down. The time required to complete the test will be recorded in seconds, with longer times indicating poorer functional mobility.
Time frame
Baseline, week 3, and week 64
Functional Reach Test
The Functional Reach Test will be used to assess dynamic balance and postural control. The maximum distance the participant can reach forward while standing without losing balance will be recorded in centimeters. Greater reach distance indicates better functional balance.
Time frame
Baseline, week 3, and week 6Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Uludag University
Lead sponsor
Mustafa Kemal University
Sponsor institution
Source ClinicalTrials.gov