Clinical trial NCT04162197: Efficacy of End-Effector Robot-Assisted Gait Training Combined With Robotic Balance Training in Subacute Stroke Patients
Official title: Efficacy of End-Effector Robot-Assisted Gait Training Combined With Robotic Balance Training in Subacute Stroke Patients: Clinical, Balance and Gait Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Robotics
Gait Training
Rehabilitation
Balance
Functional Recovery
Robot-Assisted Gait Training
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2019-11-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Over the last years, the introduction of robotic technologies in gait rehabilitation of stroke patients has aroused great interest. Some studies have been conducted to evaluate the effects of robot-assisted training compared to conventional gait rehabilitation in patients with subacute stroke but no studies seem to investigate the effects of a combined robotic treatment (gait plus balance).

The aim of this study is to evaluate the efficacy of a combined gait and balance robotic rehabilitation compared robotic gait training alone.

Detailed description: Stroke is not only the third cause of death after cardiovascular disease and cancer, but also the first cause of disability in the world with a significant impact on individuals, their families and finances. Post-stroke disability involves mobility and balance, muscle strength, control of movement, and gait pattern functions. Although the majority of stroke patients learns to walk independently by 6 months after stroke, gait and balance problems persist through the chronic stage and may have a significant impact on patients' quality of life. Accordingly, the restoration and improvement of walking functions is a primary concern to obtain independence in daily life. For this reason, gait recovery is a realist goal in the rehabilitation of almost all patients with stroke. The recovery of a more fluid, safe and correct execution of motor tasks such as gait and stair climbing are a prerequisite for the patients to become autonomous in the activities of daily living.

Over the last years, the introduction of robotic technologies in gait rehabilitation of stroke patients has aroused great interest. Some studies have been conducted to evaluate the effects of robot-assisted training compared to conventional gait rehabilitation in patients with subacute stroke. The main results were obtained using robotic exoskeletons or a treadmill training with partial body weight support and only a few studies used an end-effector device. Preliminary studies have shown that end-effector Robot-Assisted Gait Training (RAGT) has produced promising effects on motor and functional outcomes in chronic and subacute strokes patients comparing with conventional treatment. Moreover, safe gait needs a continuous dynamic balance than it is possible that in gait robotic rehabilitation could be included a rehabilitation treatment of static and dynamic balance with a robotic proprioceptive platform. The hypothesis of the study is that a combined robotic treatment (gait plus balance) could produce more effects than just one robotic gait training.

Therefore, the aim of this study is to evaluate the efficacy of gait and balance robotic rehabilitation in subacute stroke patients in terms of clinical outcomes, balance measures and gait kinematics, comparing them with robotic gait training alone.

The patients following first ever stroke in sub-acute phase will be recruited and assessed both clinically and instrumentally (Gait Analysis and Balance evaluation) at baseline (T0), after 12 sessions (T1) and at the end of the training program (24 sessions: T2). The patients will be randomized into 2 groups and will conduct two different types of rehabilitation training: one group will perform, gait training using an end-effector robotic device for RAGT (Gait Group, GG); and the other group will receive a combined robotic treatment program with the same end-effector robotic system and a robotic proprioceptive platform (Balance Group, GHG). The rehabilitation program of both groups will be combined with conventional physiotherapy.

Eligibility criteria: Inclusion Criteria:

* first cerebral stroke
* 1 month up to 6 months post the acute event (subacute patients)
* age between 18-85 years
* ability to fit into the end-effector footplates
* no significant limitation of joint range of motion
* ability to tolerate upright standing for 60 seconds
* ability to walk unassisted or with little assistance
* ability to give written consent
* compliance with the study procedures

Exclusion Criteria:

* contractures of the hip, knee, or ankle joints that might limit the range of motion during gait
* medical issue that precludes full weight bearing and ambulation (e.g. orthopaedic injuries, pain, severe osteoporosis, or severe spasticity)
* cognitive and/or communicative disability (e.g. due to brain injury): inability to understand the instructions required for the study
* cardiac pathologies, anxiety or psychosis that might interfere with the use of the equipment or testing

Primary outcomes:
measure: Change in Berg Balance Scale (BBS)
timeFrame: Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)
Secondary outcomes:
measure: Change in Motricity Index (MI)
timeFrame: Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)
measure: Change in Modified Ashworth Scale (MAS)
timeFrame: Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)
measure: Change in Tinetti Scale Balance (TIN-B)
timeFrame: Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)
measure: Change in Functional Ambulation Classification (FAC)
timeFrame: Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)
measure: Change in 10 Meter Walk Test (10MWT)
timeFrame: Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)
measure: Change in Trunk Control Test (TCT)
timeFrame: Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)
measure: Change in Time Up And Go (TUG)
timeFrame: Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)
measure: Change in Walking Handicap Scale (WHS)
timeFrame: Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)
measure: Change in Ambulation Index (AI)
timeFrame: Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)
measure: Change in Numerical Rating Scale (NRS)
timeFrame: Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)
measure: Change in Neuropathic Pain Screen (ID PAIN)
timeFrame: Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)
measure: Change in Barthel Scale/Index (BI)
timeFrame: Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)
measure: Change in Six-Minute Walking Test (6MWT)
timeFrame: Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)
Other outcomes:
measure: Gait analysis - Biomechanical data - Step width
timeFrame: Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)
measure: Gait analysis - Biomechanical data - Mediolateral distance
timeFrame: Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)
measure: Gait analysis - Biomechanical data - Longitudinal distance
timeFrame: Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)
measure: Gait analysis - Biomechanical data - Stride length
timeFrame: Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)
measure: Gait analysis - Biomechanical data - Cadence
timeFrame: Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)
measure: Gait analysis - Biomechanical data - Steps
timeFrame: Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)
measure: Gait analysis - Biomechanical data - Mean velocity of progression (mean velocity)
timeFrame: Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)
measure: Gait analysis - Biomechanical data - Mean velocity of swing (swing velocity)
timeFrame: Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)
measure: Gait analysis - Biomechanical data - Gait cycle
timeFrame: Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)
measure: Gait analysis - Biomechanical data - Stance time
timeFrame: Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)
measure: Gait analysis - Biomechanical data - Swing time
timeFrame: Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)
measure: Gait analysis - Biomechanical data - Double support
timeFrame: Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)
measure: Gait analysis - Biomechanical data - Joints flexion and extension
timeFrame: Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)
measure: Gait analysis - Biomechanical data - Joints Range of Motion (RoM)
timeFrame: Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)
measure: Balance Analysis - Stabilometric data - Velocity antero-posterior and Velocity medio-lateral (VelocityAP and VelocityML)
timeFrame: Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)
measure: Balance Analysis - Stabilometric data - Length
timeFrame: Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)
measure: Balance Analysis - Stabilometric data - Area
timeFrame: Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)
measure: Balance Analysis - Stabilometric data - Romberg Length
timeFrame: Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)
Locations:
city: Rome
country: Italy
facility: Don Gnocchi Foundation
Study officials:
affiliation: IRCCS Fondazione Don Carlo Gnocchi
name: Irene Aprile, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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