NCT02861638

Brief Summary

Postoperative rehabilitation is required for a successful outcome following total hip 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

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Shorter than P25 for not_applicable

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
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 10, 2016

Completed
Last Updated

August 12, 2020

Status Verified

August 1, 2020

Enrollment Period

5 months

First QC Date

August 5, 2016

Last Update Submit

August 10, 2020

Conditions

Total Hip Replacement

Keywords

Total hip replacementAction observation treatmentRehabilitationArthroplasty

Outcome Measures

Primary Outcomes (2)

  • Change of Pain intensity

    Visual Analogue Scale (VAS)

    Baseline and immediately post-intervention

  • Change of Range Of Motion (ROM)

    Active and passive range of motion of hip

    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. 30 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. 30 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 hip replacement.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Villafane JH, Pirali C, Isgro M, Vanti C, Buraschi R, Negrini S. Effects of Action Observation Therapy in Patients Recovering From Total Hip Arthroplasty Arthroplasty: A Prospective Clinical Trial. J Chiropr Med. 2016 Dec;15(4):229-234. doi: 10.1016/j.jcm.2016.08.011. Epub 2016 Oct 5.

    PMID: 27857630DERIVED

Related Links

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • JORGE H VILLAFAÑE, PhD

    IRCCS Don Gnocchi Foundation

    PRINCIPAL INVESTIGATOR

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

August 5, 2016

First Posted

August 10, 2016

Study Start

April 1, 2014

Primary Completion

September 1, 2014

Study Completion

October 1, 2014

Last Updated

August 12, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share