Physiotherapy and Action-Observation Therapy: An Integrated Approach for Upper Limb Impairment in Subacute Stroke

NCT04560764 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-08-12

No results posted yet for this study

Summary

Motor impairment is one of the most common result of a stroke, which causes disability and difficulties in activities of daily living. This motor impairment can concern the upper limb or the lower limb, or both. Several studies investigates the efficacy of different treatment approaches on upper limb and hand function. None of them combined exercise in a virtual context with Action Observation Therapy, consisting in watching an action before doing it.

This study evaluates the addition of Action Observation Therapy (AOT) to Virtual Reality (VR) in the rehabilitation of upper limb impairment in subacute stroke patients. Half of participants will see a video demonstrating the exercise to be performed before its actual execution, while the other half will see a video of a natural landscape followed by the same exercises the other group performs. All the patients will receive additional usual treatment.

Conditions

Interventions

DEVICE

Virtual Reality

Participants in both groups will attend 10 sessions of approximately 30 minutes each three times a week. Each session contemplates the execution of a single repetition of two minutes of each of the four exercises. There are four exercises: 1. Reaching: the participant is requested to reach a target in front of him with the paretic hand; the target will appear in a different place every time; 2. Reaching and grasping: the participant is requested to grab a wooden cube with the paretic hand and place it into a bowl positioned in front of him; the cube will appear in a different place every time; 3. Goalkeeper: the participant is requested to block a ball coming towards him with the paretic hand; the ball will appear in a different place every time; 4. Occupational task: the participant is requested to grab four cans, one at time, with the paretic hand and place them on four targets placed on a hemispherical arch. Each exercise provides six levels of increasing difficulty.

DEVICE

Action Observation Therapy

Before the execution of the exercises described in the intervention "Virtual Reality", the participants in the experimental group will see a video demonstrating the same exercise (according to the level of difficulty selected) he will be later asked to perform for two minutes.

DEVICE

Landscape video

Before the execution of the exercises described in the intervention "Virtual Reality", the participants in the sham comparator group will see a video of a natural landscape for two minutes.

OTHER

Standard treatment

Participants in both groups will receive the standard treatment, one hour a day for three days a week.

Sponsors & Collaborators

  • Fondazione Don Carlo Gnocchi Onlus

    lead OTHER

Principal Investigators

  • Riccardo Buraschi, DPT · IRCCS Fondazione Don Carlo Gnocchi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2023-06-01
Completion
2023-12-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04560764 on ClinicalTrials.gov