- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07244900
Conventional Physical Therapy Action Observation Therapy on Freezing of Gait and Functional Mobility in Parkinson's Disease
Effects Of Conventional Physical Therapy With And Without Action Observation Therapy On Freezing Of Gait And Functional Mobility In Participants With Parkinson's Disease: A Randomised Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- The University of Lahore
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria: The participants were included based on the UK Parkinson's Disease Society Brain Bank diagnostic criteria, with clinical findings supporting the diagnosis. The eligible participants were aged between 50 and 80 years, of both genders, labelled as stage ≤ 3, with a minimum of 2 years since being diagnosed with PD and a freezing of gait score of 9 or higher on FOG-Q, and able to understand and follow commands.
Exclusion Criteria:
The exclusion criteria were systemic disease and neurological issues that could affect the assessment and outcomes of treatment, implantation for deep brain stimulation, and visual or acoustic limitations.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Conventional Physiotherapy Group
This group included conventional physical therapy that contains isometric exercise, stretching techniques, and strength and balance training.
|
Group A received conventional physical therapy treatment.
The CPT program consists of isometric exercises, stretching, and strength training based on the patient's physical condition and the severity of functional mobility and freezing of Gait.
|
|
Experimental: Experimental Group
This group included action observation therapy in addition to conventional physical therapy, in which small videos containing specific task will be made available to follow to the participants.
|
Group B was given action observation therapy with conventional physical therapy treatment.
In AOT, the therapist showed small video clips of different goal-directed tasks to participants, and they were asked to follow every step and movement.
The therapist maintained the patient's attention with verbal feedback
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in functional mobility
Time Frame: The assessment was made at baseline before the treatment session, and any change in mobility status was observed at the end of 6th week and 12th week after the intervention.
|
The TUG is an efficient test that measures mobility and balance, requiring participants to rise from a chair, walk 3 meters, turn, walk back, and sit down.
The time taken to complete this sequence is recorded, with longer times indicating potential mobility issues.
A score of more than or equal to fourteen seconds indicates a high risk of falls.
|
The assessment was made at baseline before the treatment session, and any change in mobility status was observed at the end of 6th week and 12th week after the intervention.
|
|
Change in Freezing of gait
Time Frame: The freezing of gait was assessed at baseline, and any change in it was measured at the end of 6th week and 12th week after the intervention.
|
The FOG-Q is a reliable tool for evaluating the effectiveness of treatment intervention on FOG for Parkinson's disease.
The questionnaire consists of 6 items designed to assess the severity of freezing of gait.
Each item is rated on a five-point Likert scale, with '0' indicating no symptoms and '4' indicating the most severe symptoms.
The total score can range from 0 to 24, with higher scores indicating greater severity of freezing of gait.
|
The freezing of gait was assessed at baseline, and any change in it was measured at the end of 6th week and 12th week after the intervention.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ishfaq Ahmed, PhD Physiotherapy, University of Lahore
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Kiran Maqsood
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Access to the de-identified individual participant data (IPD) and supporting documents will be available to qualified researchers affiliated with recognized academic or research institutions. Interested researchers may request access by submitting a written proposal outlining the study objectives and analysis plan to the principal investigator or corresponding author.
Upon approval, the data (including de-identified participant-level datasets, study protocol, and statistical analysis plan) will be shared via a secure institutional data repository or encrypted email. Data will be provided solely for non-commercial, academic research purposes and must comply with applicable ethical and data protection standards.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parkinson Disease
-
Bezmialem Vakif UniversityRecruitingParkinson Disease | Parkinson | Parkinson Disease (PD) | PARKINSON DISEASE (Disorder) | Parkinson s DiseaseTurkey (Türkiye)
-
CND Life SciencesDigestive Disease Associates of CTRecruitingParkinson Disease | Parkinson | PARKINSON DISEASE (Disorder) | Parkinson s DiseaseUnited States
-
Neuron23 Inc.Roche Diagnostic Ltd.; Qiagen Manchester LimitedRecruitingParkinson Disease | Parkinson | Idiopathic Parkinson Disease | Parkinson Disease, Idiopathic | Early Parkinson Disease (Early PD)United States, Spain, Israel, Poland, Italy, United Kingdom
-
San Francisco Neurology and Sleep CenterNot yet recruitingPARKINSON DISEASE (Disorder) | Parkinson s DiseaseUnited States
-
Haukeland University HospitalUniversity of Bergen; SPARK NSRecruitingParkinson Disease (PD) | Parkinson s DiseaseNorway
-
CND Life SciencesOregon Health and Science UniversityRecruitingParkinson Disease | Parkinson | Parkinson's Disease and Parkinsonism | PARKINSON DISEASE (Disorder)United States
-
Università degli Studi dell'InsubriaUniversidade Nova de Lisboa; Associazione Parkinson Insubria (AsPI), Section... and other collaboratorsRecruitingParkinson Disease | Parkinson | Parkinson Disease, Idiopathic | PARKINSON DISEASE (Disorder)Italy
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedParkinson Disease 6, Early-Onset | Parkinson Disease (Autosomal Recessive, Early Onset) 7, Human | Parkinson Disease Autosomal Recessive, Early Onset | Parkinson Disease, Autosomal Recessive Early-Onset, Digenic, Pink1/Dj1United States
-
Duke UniversityMedical University of South Carolina; Massachusetts General Hospital; Mayo Clinic and other collaboratorsNot yet recruitingGut Microbiota | Gut Microbiome | Parkinson Disease (PD) | PARKINSON DISEASE (Disorder) | Prodromal Parkinsons DiseaseUnited States
-
ProgenaBiomeWithdrawnParkinson Disease | Parkinsons Disease With Dementia | Parkinson-Dementia Syndrome | Parkinson Disease 2 | Parkinson Disease 3 | Parkinson Disease 4United States
Clinical Trials on Conventional Physical Therapy
-
Riphah International UniversityCompletedAdhesive Capsulitis of ShoulderPakistan
-
Riphah International UniversityNot yet recruitingCervical RadiculopathyPakistan
-
Federal University of BahiaFundação de Amparo à Pesquisa do Estado da BahiaUnknown
-
University of LahoreCompletedCerebral Palsy (CP) | Quadriplegic Cerebral PalsyPakistan
-
Universidad Catolica Silva HenriquezAgencia Nacional de Investigacion y Desarrollo, ANIDActive, not recruiting
-
Kars State HospitalCompletedShoulder Pain | Myofascial Pain | HemiplegiaTurkey
-
University of ValenciaCompleted
-
University of LahoreCompletedDiabetic NeuropathiesPakistan
-
University of LahoreCompletedLow Back Pain, MechanicalPakistan
-
Riphah International UniversityCompleted