Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT01678547 |
| Other study ID # |
RP 19/12 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 2012 |
| Est. completion date |
September 2015 |
Study information
| Verified date |
April 2024 |
| Source |
IRCCS San Raffaele Roma |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Stroke are the main causes of motor disability among adults and are expected to impose an
increasing social and economic burden for our Country. The impact of stroke on patients is
enormous, with negative ramifications on the persons participation in social, vocational, and
recreational activities. It is the primary cause of long-term disability in these countries.
At the present stage, it is well known that control of balance during upright standing
depends upon the central integration of afferent information from vestibular, somatosensory
(proprioceptive, tactile), and visual systems, which constitute a multilink neural network
for the control of neck, hip, and ankle joints. More recently, it has been studied at the
level of cerebral cortex; vestibular inputs would reach face/neck representation of primary
somatosensory cortex and would be then integrated with visual and somatosensory inputs in
intraparietal, posterior end of the insula and medial superior temporal cortices. Remarkably,
balance impairment and the associated risk of falling represent one of the most prominent and
potentially disabling features in stroke subjects. The specific aims of this project are: to
verify whether the robotics lower limb treatment with body weight support is more effective
than the treadmill treatment in the reduction of motor impairment in Stroke patients, and to
improve the quality of the gait and the endurance and to analyze possible improvements in
terms of physiological biomechanical gait through analysis of spatio-temporal parameters.
Description:
Objective: to assess the lower limb recovery after the gait rehabilitation training exercises
in acute and chronic stroke patients.
The proposed project, through a Randomized controlled observer-blind trial aimed at
evaluating the effectiveness of end-effector robot assisted therapy vs the treadmill and
ground treatment in sub-acute and chronic stroke subjects. 90 inpatients and out-patients
with a stroke will be recruited. We will randomize the patients on 3 groups [15 sub-acute
(ischemic and hemorrhagic) stroke patients (after 30±7 days from injury) and 15 chronic
(ischemic and hemorrhagic) patients (after 3/6 months days from injury) for all groups]:
1. sub-acute and chronic stroke patients robot treatment.
2. sub-acute and chronic patients treadmill treatment.
3. sub-acute and chronic patients ground treatment.
The specific aims of this project are:
1. to verify whether the robotics end-effector GEO lower limb treatment with body weight
support is more effective than the treadmill treatment or ground treatment in the
reduction of motor impairment in sub-acute and Chronic stroke patients, and to improve
the quality of the gait and the endurance;
2. to analyse possible improvements in terms of physiological biomechanical gait through
analysis of kinematics , kinetics and EMG evaluation;
3. to analyse possible improvements in terms of reduction of instable posture and
movements, which can represent a reduction of the risk of fall typical of these
subjects;
4. to evaluate the kinematic, kinetic and EMG quantitative data during selected movements
(gait, posture, ) compared with age matched reference data;
5. to investigate the stability of the effects of robot-assisted treatment at 4/6 months
follow-up in terms of Quality of Life (QoL).
A first goal of this project is to investigate the differences in improvement of the quality
and safety of the gait (motor performance and functional recovery) through kinematic/kinetic
and EMG parameters (Change in Step Length, Change in Gait Velocity and Change in Stride Time
Variability, 3D joints kinematics, ground reaction forces, joint kinetics, muscle
activation,) and traditional clinical scales in sub-acute and chronic stroke patients.
The second goals is aimed at identifying possible advantages in the QoL of patients
undergoing such a kind of in-patients and out-patients rehabilitation treatment and at
investigating novel methods enabling lower limb functional recovery, leading to wide
potential for regaining personal independence.
The third goal is to analyse direct cost savings associated with the use of such
technologies, measured as direct, indirect and intangible costs, through specific HTA
procedures.
