Effectiveness of an Exoskeleton Gait Training Versus Manual Therapy in Subacute Post Stroke Patients.
1 other identifier
interventional
28
1 country
2
Brief Summary
The main objective of the present study was to compare the effects of exoskeleton devices used in electromechanical-assisted gait training after stroke compared to over ground conventional physical therapy in a single blind research. The second objective is to research when the devices can be used with the best chance of success in the functional recovery of gait in people who are unable to walk independently after stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable stroke
Started Mar 2014
Shorter than P25 for not_applicable stroke
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2014
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedFirst Posted
Study publicly available on registry
March 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedMarch 31, 2014
March 1, 2014
2 months
February 27, 2014
March 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Gait performances
All evaluation procedures are performed by the same examiner who was blinded to the aims of the study and to which group the participants are allocated. The 6-Minute Walk Test (6MWT) and 10 meters walking test are used to assess endurance and speed, respectively. The 6MWT quantifies functional mobility based on the distance in meters traveled in 6 minutes. This outcome is a measure of endurance and is particularly significant to evaluate the possibility to perform continuative tasks, that are particularly important for the rehabilitation of stroke patients and are relevant for an autonomous life. The speed is quantified with the 10-meters Walk Test (TWT) over the ground. The gait speed measurement is performed over the middle six meters of the TWT and patients are asked to walk at their comfortable speed.
1 day before the treatment
Gait performances
All evaluation procedures are performed by the same examiner who was blinded to the aims of the study and to which group the participants are allocated. The 6-Minute Walk Test (6MWT) and 10 meters walking test are used to assess endurance and speed, respectively. The 6MWT quantifies functional mobility based on the distance in meters traveled in 6 minutes. This outcome is a measure of endurance and is particularly significant to evaluate the possibility to perform continuative tasks, that are particularly important for the rehabilitation of stroke patients and are relevant for an autonomous life. The speed is quantified with the 10-meters Walk Test (TWT) over the ground. The gait speed measurement is performed over the middle six meters of the TWT and patients are asked to walk at their comfortable speed.
1 day after the treatment
Gait performances
All evaluation procedures are performed by the same examiner who was blinded to the aims of the study and to which group the participants are allocated. The 6-Minute Walk Test (6MWT) and 10 meters walking test are used to assess endurance and speed, respectively. The 6MWT quantifies functional mobility based on the distance in meters traveled in 6 minutes. This outcome is a measure of endurance and is particularly significant to evaluate the possibility to perform continuative tasks, that are particularly important for the rehabilitation of stroke patients and are relevant for an autonomous life. The speed is quantified with the 10-meters Walk Test (TWT) over the ground. The gait speed measurement is performed over the middle six meters of the TWT and patients are asked to walk at their comfortable speed.
60 days after the treatment
Secondary Outcomes (30)
Functional outcomes
1 day before the treatment
Functional outcomes
1 day before the treatment
Functional outcomes
1 day before the treatment
Functional outcomes
1 day before the treatment
Functional outcomes
1 day before the treatment
- +25 more secondary outcomes
Study Arms (2)
Technological Rehabilitation
EXPERIMENTALPatients in the experimental group received a multimodal treatment intervention consisting of 60 minutes of conventional treatment according to the Bobath approach (Bobath B. Adult hemiplegia: evaluation and treatment. Oxford: Butterworth-Heineman, 1990) followed by 30 minutes of robotic gait training on the Lokomat robotic system with the supervision of an expert rehabilitator. Patients started the first session with 50% weight unload and 1.5 Km/h gait speed, performances increments are allowed only in the following sessions. Each patient received 20 sessions over a period of 4 weeks (5 sessions per week).
Control Rehabilitation
ACTIVE COMPARATORPatients in the control group received the same number of treatment sessions of a similar duration as those in the experimental group but they received activities of overground walking exercises targeted to improve walking in substitution of the robotic gait trainer.
Interventions
The Lokomat (Hocoma, Zurich, Switzerland) is robotic device conformed as an exoskeleton on the lower limbs of the patient. Through active and passive actuators, it realize a proper trajectory with an associated motion profile of the involved limbs. The results are physically guide repetitive, rhythmic, bilateral lower extremity movements in order to simulate a physiological gait cycle.The system uses a dynamic body weight-support system to support the participant above a motorized treadmill synchronized with the Lokomat. Participants were provided verbal encouragement to actively step in conjunction with the movement presented by the Lokomat.
When needed, more than one therapist are employed in the intervention for safety reasons.
Eligibility Criteria
You may qualify if:
- hemiparesis at least six months from stroke.
You may not qualify if:
- Ashworth scale \>3
- Bone instability (unconsolidated fractures, vertebral instability, severe osteoporosis),
- Articular ankyloses, contractures
- Spasms with locomotion effects
- Mini Mental State Examination (MMSE) \[???\] \< 22 points and behavioral diseases involving aggressivity or psychotic disorders
- Clinicopathological conditions contraindicating the rehabilitation treatment (respiratory insufficiency, cardiac/circulatory failure, osteomyelitis, phlebitis and other conditions)
- Cutaneous lesions at lower limbs
- Weight \> 135 kg
- Height \> 200 cm
- Dysmetria of lower limbs more than 2 cm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Habilta Zingonia
Ciserano, BG, 24040, Italy
Habilita Sarnico
Sarnico, BG, 24067, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giovanni Taveggia, Physician
Habilita, Ospedale di Sarnico
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 INVESTIGATOR
- PI Title
- Medical Director
Study Record Dates
First Submitted
February 27, 2014
First Posted
March 26, 2014
Study Start
March 1, 2014
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
March 31, 2014
Record last verified: 2014-03