The REACTplusNMES Trial: A Double-blinded RCT
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity of Illinois at Chicago
About this trial
The aim of this study is to compare the effectiveness of 6-weeks of reactive balance training (REACT) with and without neuromuscular electrical stimulation (NMES) to paretic lower limb muscles on biomechanical, clinical, neuromuscular and neuroplastic outcomes of reactive balance control. This project is a Phase-I study and incorporates a double-blinded, randomized controlled trial design.
Methods: Forty-six individuals with chronic stroke will be recruited and screened for determining their eligibility for the study. Once enrolled, they will be randomized into either of the two groups: intervention group (23 participants) and control group (23 participants). Both groups will undergo series of pre-training assessments which includes a postural disturbance in the form of a slip- or trip-like perturbations and walking tests in laboratory environment. After the pre-training assessment, individuals will undergo 6-weeks of training (2 hour per session, 2 sessions per week). The intervention group will receive NMES with the REACT training and the control group will receive ShamNMES. NMES will be applied to the different muscle groups of the paretic lower limb using an advanced software which is able to synchronize muscle activation with the time of perturbation onset and according to the phases of gait. After training, both groups will again be tested on all the assessments performed pre training.
This study will help us understand the immediate therapeutic and mechanistic effects of REACT+NMES and inform stroke rehabilitation research and clinical practice. Our study will provide foundational evidence for future use of NMES to implement clinically applicable neuromodulation adjuvants to reactive balance training, which could be leveraged for designing more effective future interventions for fall-risk reduction.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age group: 18-90 years.
Presence of hemiparesis.
Onset of stroke (> 6 months).
Ability to walk at least for 2 minutes on the treadmill with or without ankle foot orthosis.
Disqualifiers
Subjects will not proceed with the test if any of the following occurs at baseline measurement: 1) HR > 85% of age-predicted maximal heart rate (HRmax) (HRmax = 220 - age), 2) systolic blood pressure (SBP) > 165 mmHg and/or diastolic blood pressure (DBP) > 110 mmHg during rest, or 3) oxygen saturation (measured by pulse oximeter) < 95% during rest.
Body weight of more than 250 lbs.
Spasticity (Ashworth scale > 2).
Loss of protective sensations on the paretic leg (indicated by inability to perceive the 5.07/10 g on Semmes-Weinstein Monofilament) or inability to feel the NMES.
Trial design
Design model
Parallel
Treatments tested in this trial
Reactive balance training with Neuromuscular Electrical Stimulation
BehavioralREACT-NMES group: The ActiveStep treadmill will be used to deliver slips during all sessions. Each subject will experience three levels of perturbations over 12 sessions (24 slips/session) in progressive ascending way. On the first week, subjects will start with the lowest displacement level (6 cm) and move up to the next level (12 cm) by week 2 if they have \< 5 falls out of 8 slips at the previous level. By week 3, subjects are expected to move to level 3 (24 cm) and train at that for weeks 3 to 6. If subjects don't move up a level, training will continue at the lower level. NMES will be delivered to the vastus lateralis synchronously with the perturbation, which will always occur 50 ms after slip-onset and last for 450 ms including the period between liftoff to touchdown of the first compensatory step.
Reactive balance training without Neuromuscular Electrical Stimulation
BehavioralREACT group: The REACT group will undergo the same reactive balance training (in terms of type, dosage: intensity, frequency) as the REACT-NMES group. The only difference will be that the REACT group will receive ShamNMES for same time after the compensatory step touchdown. The ActiveStep treadmill will be used to deliver slips during all sessions. Each subject will experience three levels of perturbations over 12 sessions (24 slips/session) in progressive ascending way. On the first week, subjects will start with the lowest displacement level (6 cm) and move up to the next level (12 cm) by week 2 if they have \< 5 falls out of 8 slips at the previous level. By week 3, subjects are expected to move to level 3 (24 cm) and train at that for weeks 3 to 6. If subjects don't move up a level, training will continue at the lower level.
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: REACT-NMES: Intervention conditionExperimental treatment 1 intervention
Group B: REACT: Control conditionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Falls
A fall will be detected when the force exerted through the safety-harness load cell exceeds 30% of a person's body weight and verified with video analysis. Otherwise, the trial will be a balance recovery. Higher percentages indicate more falls.
Time frame
Pre-training (during week 2 i.e., Session 2), Post-training (during week 9 i.e., Session 16)2
Change in Reactive Stability
Reactive stability (dimensionless) will be measured at the time point of compensatory limb touchdown after slipping. Stability will be calculated as the shortest distance from the COM state to the backward balance loss threshold. The instantaneous COM state is determined by its position and velocity (computed from filtered marker data) relative to the BOS, normalized respectively to foot length and the square root of the product of gravitational acceleration and body height. Higher values indicate better reactive stability.
Time frame
Pre-training (during week 2 i.e., Session 2), Post-training (during week 9 i.e., Session 16)3
Change in Proactive Stability
Proactive stability (dimensionless) will be measured at the time point of slipping limb touchdown i.e., before slipping. Stability will be calculated as the shortest distance from the COM state to the backward balance loss threshold. The instantaneous COM state is determined by its position and velocity (computed from filtered marker data) relative to the BOS, normalized respectively to foot length and the square root of the product of gravitational acceleration and body height. Higher values indicate better proactive stability.
Time frame
Pre-training (during week 2 i.e., Session 2), Post-training (during week 9 i.e., Session 16)4
Change in Vertical Limb support
Vertical limb support (dimensionless) is quantified by the quotient of hip vertical velocity to its height (VZhip/ Zhip). Zhip will be obtained as the vertical distance of the bilateral hip midpoint to the surface of the platform and its vertical velocity (VZhip), as the first-order differentiation of hip height. Its positive direction is upward. Higher values indicate better vertical limb support.
Time frame
Pre-training (during week 2 i.e., Session 2), Post-training (during week 9 i.e., Session 16)Secondary outcomes
1
Change in Margin of Stability
Margins of stability (dimensionless) will be computed by determining the distance between the center of mass (COM) position and a person's base of support through the three-dimensional motion analysis system. Higher values indicate a better margin of stability.
Time frame
Pre-training (during week 2 i.e., Session 2), Post-training (during week 9 i.e., Session 16)2
Change in Step length
Compensatory step length (meters) is the distance from slipping heel to compensatory heel at the instance of first limb touchdown post-slipping. Negative values indicated a backward compensatory step relative to the slipping limb, with greater negative values indicated a longer step and vice versa.
Time frame
Pre-training (during week 2 i.e., Session 2), Post-training (during week 9 i.e., Session 16)3
Change in Step initiation time
Compensatory step initiation time (seconds) is the time taken for liftoff of the compensatory limb after perturbation onset. Lower values indicated better performance i.e., lesser time required to initiate a compensatory step following slip onset.
Time frame
Pre-training (during week 2 i.e., Session 2), Post-training (during week 9 i.e., Session 16)Sponsors and contacts
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Source ClinicalTrials.gov