NCT06000345

Brief Summary

The study aims at evaluating the effects of one session of Action Observation Training (AOT) and Motor Imagery (MI) on arthrogenic muscle inhibition (AMI) of the quadriceps (QF) in subjects with end-stage gonarthrosis. 30 patients with end-stage knee osteoarthritis were enrolled. Patients were randomized in two groups (experimental group and control group). Experimental group performed one 6-minutes AOT and MI session with motor content of concentric and isometric QF contractions, whereas control group underwent a 6-minute sham AOT and MI session. Every patient was evaluated to assess the percentage of AMI on the QF before (T0) and after (T1) the treatment following the gold standard Twitch Interpolated Technique.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

9 months

First QC Date

August 3, 2023

Last Update Submit

August 16, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in arthrogenic muscle inhibition (estimated through Interpolated Twitch Technique)

    Changes in arthrogenic muscle inhibition (AMI) of the quadriceps muscle before and after AOT and MI session on patients with advanced stage gonarthrosis.

    1- Before AOT+MI session; 2- Immediately after AOT+MI session

Study Arms (2)

AOT + MI group

EXPERIMENTAL

The AOT + MI group was shown a video (4 minutes) in which a subject (matched for age, sex, and limb affected) performed, in third person view, quadriceps concentric contractions for 2 minutes and isometric contractions for 2 minutes. The video contained visual elements indicating the maximality of the effort. After both concentric and isometric movement video the subjects performed a MI session (1 minute in length each), in which they were asked to imagine in first person the action previously observed in the video.

Other: AOT + MI

Control group

SHAM COMPARATOR

The control group was shown a video of landscapes (4 minutes in length). Halfway through and at the end of the video they were asked to imagine what they had just seen for 1 minute.

Other: Control AOT + MI

Interventions

During the AOT session, the patients were shown a video containing motor contents. In particular, the video demonstrated quadriceps concentric and isometric contractions, presented in the third person perspective. At the conclusion of each video, the patients were asked to spend 1 minute imagining what they had just seen.

AOT + MI group

The control group was shown a video of landscapes (4 minutes in length). Halfway through and at the end of the video they were asked to imagine what they had just seen for 1 minute.

Control group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with end-stage knee ostheoarthritis undergoing primary total knee arthroplasty
  • Active knee flexion \> 45°

You may not qualify if:

  • Previous lower limb orthopedic surgery
  • Concomitant neurological, orthopedic, cardiovascular disorders
  • Cognitive impairments or psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, 20089, Italy

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

August 3, 2023

First Posted

August 21, 2023

Study Start

January 1, 2023

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

August 21, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations