NCT02707419

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2014

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 14, 2016

Completed
Last Updated

March 14, 2016

Status Verified

March 1, 2016

Enrollment Period

5 months

First QC Date

February 27, 2016

Last Update Submit

March 8, 2016

Conditions

Total Knee Replacement

Keywords

Total knee replacementAction observation treatmentRehabilitation

Outcome Measures

Primary Outcomes (2)

  • Change of Pain intensity

    Visual Analogue Scale

    Baseline and immediately post-intervention

  • Change of Range Of Motion

    Active and passive range of motion of knee

    Baseline and immediately post-intervention

Secondary Outcomes (4)

  • Barthel index

    Baseline and immediately post-intervention

  • Short Form-36 motor

    Baseline and immediately post-intervention

  • Tinetti scale

    Baseline and immediately post-intervention

  • Lequesne index

    Baseline and immediately post-intervention

Study Arms (2)

Experimental group

EXPERIMENTAL

Video of the exercises and conventional physiotherapy. 45 minutes twice a day, 5 days a week for 2 weeks.

Device: Experimental groupDevice: Conventional physiotherapy

Control group

ACTIVE COMPARATOR

Video of nature scenes and conventional physiotherapy. 45 minutes twice a day, 5 days a week for 2 weeks.

Device: Control groupDevice: Conventional physiotherapy

Interventions

Experimental groupDEVICE

Video of the exercises

Experimental group
Control groupDEVICE

video of nature scenes

Control group
Conventional physiotherapyDEVICE

Mobilization, exercises and transfer practice.

Control groupExperimental group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary total knee replacement.

You may not qualify if:

  • bilateral knee replacement
  • previous total knee replacement.
  • pre-existing motor impairment (i.e. hemiparesis, poliomyelitis, lumbar sciatica);

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jorge Hugo Villafañe

Piossasco, Turin, 10045, Italy

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

February 27, 2016

First Posted

March 14, 2016

Study Start

April 1, 2014

Primary Completion

September 1, 2014

Study Completion

October 1, 2014

Last Updated

March 14, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)