NCT07244900

Brief Summary

The goal of this study is to determine the effects of action observation therapy with conventional physical therapy on freezing gait and functional limitation in participants with Parkinson's disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Jun 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

November 17, 2025

Last Update Submit

November 17, 2025

Conditions

Keywords

Parkinson's DiseaseBalanceFreezing of GaitMobilityFunction

Outcome Measures

Primary Outcomes (2)

  • Change in functional mobility

    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

    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.

Study Arms (2)

Conventional Physiotherapy Group

ACTIVE COMPARATOR

This group included conventional physical therapy that contains isometric exercise, stretching techniques, and strength and balance training.

Other: Conventional Physical Therapy

Experimental Group

EXPERIMENTAL

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.

Other: Action Observation plus conventional Physical Therapy

Interventions

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.

Conventional Physiotherapy Group

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

Experimental Group

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ishfaq Ahmed, PhD Physiotherapy

    University of Lahore

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
This study will use a single-blind masking design, in which the outcome assessor will be blinded to group allocation. Participants and therapists will be aware of the intervention assigned, but the assessor responsible for data collection and analysis will not have access to group assignment information to minimize assessment bias.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study follows a parallel group design, involving two groups: a control group and an experimental group. Participants in both groups will receive treatment concurrently but under different conditions. The control group will receive the standard or conventional intervention, while the experimental group will receive the modified or additional treatment being investigated. Comparisons between the groups will be made to evaluate the effectiveness of the experimental intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

November 24, 2025

Study Start

June 1, 2023

Primary Completion

June 1, 2024

Study Completion

July 1, 2024

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) that underlie the results reported in the study will be shared.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Three years after the publication of result findings
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.
More information

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