Clinical trial NCT04087083: Innovative Models in the Rehabilitation of the Elderly With Stroke Through Technological Innovation
Official title: Assistive Robotic in the Elderly: Innovative Models in the Rehabilitation of the Elderly With Stroke Through Technological Innovation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Aging Problems
Innovative Rehabilitation Treatment Based on Robotics
Keywords: stroke
robotic rehabilitation
frail elderly
gait performance
balance
risk of falling
quality of life
Lead sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Sponsor class: OTHER
First posted: 2019-09-12
Enrollment: 150
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The final goal of the present study is to propose a new approach and an innovative therapeutic plan in the post-stroke rehabilitation of elderly patients, focused on the use of robotic device, in order to obtain the beneficial effects of this treatment.

Detailed description: Stroke is a leading cause of disability, injury, and death in elderly people and represents a major public health problem with substantial medical and economic consequences. The incidence of stroke rapidly increases with age, doubling for each decade after age 55 years. Gait impairment is one of the most important problems after stroke and improve walking function is often a key component of any rehabilitation program. To achieve this goal, robotic gait trainer seems to be promising. In fact, some studies underline the efficacy of robotic gait training based on end-effector technology, for different diseases, in particular in stroke patients. In this randomized controlled trial, we verify the efficacy of the robotic treatment in terms of improving the gait and reducing the risk of falling and its long-term effects.

In this single blind randomized controlled trial the investigators will include 150 elderly subacute stroke patients divided in two groups to receive a traditional rehabilitation program or a robotic rehabilitation using G-EO system, an end-effector device for the gait rehabilitation, in addition to the traditional therapy. A 20 treatment sessions will be conducted, divided into 3 training sessions per week, for 7 weeks. The control group will perform traditional therapy sessions lasting 50 minutes. The technological intervention group, using G-EO system, will carry out 30 minutes of traditional therapy and 20 minutes of treatment with a robotic system. The primary outcome of the study is the evaluation of the falling risk. Secondary outcomes are the assessment of the gait improvements and the fear of falling. Further evaluations, such as length and asymmetry of the step, walking and functional status, acceptance of the technology, will be carried.

Eligibility criteria: Inclusion Criteria:

* Capacity to consent
* Ischemic or hemorrhagic stroke within 3 months to the recruitment, proven by computerized axial tomography or nuclear magnetic resonance
* Functional Ambulation Category (FAC) score ≤ 2
* Ranking scale score ≤ 3
* Complete communication and comprehension skills, assessed during the objective examination
* Ability to stand upright, supported or unsupported, for 1 minute

Exclusion Criteria:

* Concomitant participation in other studies
* Severe hypertonus of the hip, knee, ankle of the paretic leg with a modified Ashworth scale score ≥3
* Severe hip, knee or ankle contracture or orthopedic problem affecting ambulation that would preclude passive range of motion of the paretic leg
* Deep vein thrombosis of the lower limbs
* Other cognitive, motor and sensory deficits that negatively condition robotic training
* Treatment of spasticity of the lower limb within 3 months to the start of the study or during the study
* Lack of written informed consent
* Clinical dementia rating (CDR) score ≥ 3
* Severe systemic diseases with life expectancy \< 1 year

Primary outcomes:
measure: difference in falling risk between experimental arm and control arm
timeFrame: before treatment, at the end of rehabilitation sessions and 6 months, 12 months and 24 months after intervention
Secondary outcomes:
measure: difference in gait performance between experimental arm and control arm
timeFrame: before treatment, at the end of rehabilitation sessions and 6 months, 12 months and 24 months after intervention
measure: difference in fear of falling between experimental arm and control arm
timeFrame: before treatment, at the end of rehabilitation sessions and 6 months, 12 months and 24 months after intervention
measure: difference in quality of life between experimental arm and control arm: SF-12 health survey
timeFrame: before treatment, at the end of rehabilitation sessions and 6 months, 12 months and 24 months after intervention
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: IRCCS INRCA Hospital
city: Fermo
country: Italy
facility: IRCCS INRCA Hospital
Study officials:
References:
citation: Maranesi E, Bevilacqua R, Di Rosa M, Pelliccioni G, Di Donna V, Luzi R, Morettini M, Sbrollini A, Casoni E, Rinaldi N, Baldoni R, Lattanzio F, Burattini L, Riccardi GR. An innovative training based on robotics for older people with subacute stroke: study protocol for a randomized controlled trial. Trials. 2021 Jun 14;22(1):400. doi: 10.1186/s13063-021-05357-8.