- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02707419
Action Observation in Knee Replacement
Self-administered Action Observation Treatment Enhance the Efficacy of Inpatient Rehabilitation After Total Knee Replacement: A Randomized Controlled Trial
Postoperative rehabilitation is required for a successful outcome following total knee arthroplasty. Traditionally rehabilitative programs aim to increase range of motion, to strengthen quadriceps, to restore normal gait, and to recover independence in activities of daily living. In the last decade action observation treatment, in addition to conventional physiotherapy has been proposed as a treatment method in rehabilitative medicine. There is growing evidence of the applicability of action observation training in rehabilitative medicine, indeed it has been applied in the rehabilitation of stroke of Parkinson disease of cerebral palsy and of aphasia.
Nevertheless those are small studies and one of them included a mixed population of hip and knee arthroplasty.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Turin
-
Piossasco, Turin, Italy, 10045
- Jorge Hugo Villafañe
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Primary total knee replacement.
Exclusion Criteria:
- bilateral knee replacement
- previous total knee replacement.
- pre-existing motor impairment (i.e. hemiparesis, poliomyelitis, lumbar sciatica);
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
Video of the exercises and conventional physiotherapy.
45 minutes twice a day, 5 days a week for 2 weeks.
|
Video of the exercises
Mobilization, exercises and transfer practice.
|
|
Active Comparator: Control group
Video of nature scenes and conventional physiotherapy.
45 minutes twice a day, 5 days a week for 2 weeks.
|
Mobilization, exercises and transfer practice.
video of nature scenes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of Pain intensity
Time Frame: Baseline and immediately post-intervention
|
Visual Analogue Scale
|
Baseline and immediately post-intervention
|
|
Change of Range Of Motion
Time Frame: Baseline and immediately post-intervention
|
Active and passive range of motion of knee
|
Baseline and immediately post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Barthel index
Time Frame: Baseline and immediately post-intervention
|
Barthel index
|
Baseline and immediately post-intervention
|
|
Short Form-36 motor
Time Frame: Baseline and immediately post-intervention
|
Baseline and immediately post-intervention
|
|
|
Tinetti scale
Time Frame: Baseline and immediately post-intervention
|
Baseline and immediately post-intervention
|
|
|
Lequesne index
Time Frame: Baseline and immediately post-intervention
|
Baseline and immediately post-intervention
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Dongnocchi
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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