Multicenter Randomized Clinical Trial Evaluating the Effectiveness of the Lokomat in Subacute Stroke

2008 ◽  
Vol 23 (1) ◽  
pp. 5-13 ◽  
Author(s):  
Joseph Hidler ◽  
Diane Nichols ◽  
Marlena Pelliccio ◽  
Kathy Brady ◽  
Donielle D. Campbell ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Outcome Measures ◽  
Walking Speed ◽  
Gait Training ◽  
Secondary Outcome ◽  
Walking Ability ◽  
Robotic Assisted ◽  
Subacute Stroke

Objective. To compare the efficacy of robotic-assisted gait training with the Lokomat to conventional gait training in individuals with subacute stroke. Methods. A total of 63 participants <6 months poststroke with an initial walking speed between 0.1 to 0.6 m/s completed the multicenter, randomized clinical trial. All participants received twenty-four 1-hour sessions of either Lokomat or conventional gait training. Outcome measures were evaluated prior to training, after 12 and 24 sessions, and at a 3-month follow-up exam. Self-selected overground walking speed and distance walked in 6 minutes were the primary outcome measures, whereas secondary outcome measures included balance, mobility and function, cadence and symmetry, level of disability, and quality of life measures. Results. Participants who received conventional gait training experienced significantly greater gains in walking speed ( P = .002) and distance ( P = .03) than those trained on the Lokomat. These differences were maintained at the 3-month follow-up evaluation. Secondary measures were not different between the 2 groups, although a 2-fold greater improvement in cadence was observed in the conventional versus Lokomat group. Conclusions. For subacute stroke participants with moderate to severe gait impairments, the diversity of conventional gait training interventions appears to be more effective than robotic-assisted gait training for facilitating returns in walking ability.

Robotic-assisted gait training in Parkinson's disease: a three-month follow-up randomized clinical trial

2017 ◽  
Vol 127 (11) ◽  
pp. 996-1004 ◽  
Author(s):  
Anna Furnari ◽  
Rocco Salvatore Calabrò ◽  
Maria Cristina De Cola ◽  
Michelangelo Bartolo ◽  
Alberto Castelli ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Clinical Trial ◽  
Parkinson's Disease ◽  
Randomized Clinical Trial ◽  
Gait Training ◽  
Robotic Assisted

scholarly journals A randomized clinical trial of a theory-based fentanyl overdose education and fentanyl test strip distribution intervention to reduce rates of opioid overdose: study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Brendan P. Jacka ◽  
Jacqueline E. Goldman ◽  
Jesse L. Yedinak ◽  
Edward Bernstein ◽  
Scott E. Hadland ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Behavior Change ◽  
Randomized Clinical Trial ◽  
Study Protocol ◽  
Test Strip ◽  
Health Concern ◽  
Secondary Outcome ◽  
Opioid Overdose ◽  
Test Strips

Abstract Background Opioid overdose deaths involving synthetic opioids, particularly illicitly manufactured fentanyl, remain a substantial public health concern in North America. Responses to overdose events (e.g., administration of naloxone and rescue breathing) are effective at reducing mortality; however, more interventions are needed to prevent overdoses involving illicitly manufactured fentanyl. This study protocol aims to evaluate the effectiveness of a behavior change intervention that incorporates individual counseling, practical training in fentanyl test strip use, and distribution of fentanyl test strips for take-home use among people who use drugs. Methods Residents of Rhode Island aged 18–65 years who report recent substance use (including prescription pills obtained from the street; heroin, powder cocaine, crack cocaine, methamphetamine; or any drug by injection) (n = 500) will be recruited through advertisements and targeted street-based outreach into a two-arm randomized clinical trial with 12 months of post-randomization follow-up. Eligible participants will be randomized (1:1) to receive either the RAPIDS intervention (i.e., fentanyl-specific overdose education, behavior change motivational interviewing (MI) sessions focused on using fentanyl test strips to reduce overdose risk, fentanyl test strip training, and distribution of fentanyl test strips for personal use) or standard overdose education as control. Participants will attend MI booster sessions (intervention) or attention-matched control sessions at 1, 2, and 3 months post-randomization. All participants will be offered naloxone at enrolment. The primary outcome is a composite measure of self-reported overdose in the previous month at 6- and/or 12-month follow-up visit. Secondary outcome measures include administratively linked data regarding fatal (post-mortem investigation) and non-fatal (hospitalization or emergency medical service utilization) overdoses. Discussion If the RAPIDS intervention is found to be effective, its brief MI and fentanyl test strip training components could be easily incorporated into existing community-based overdose prevention programming to help reduce the rates of fentanyl-related opioid overdose. Trial registration ClinicalTrials.gov NCT04372238. Registered on 01 May 2020

scholarly journals Allowing Intralimb Kinematic Variability During Locomotor Training Poststroke Improves Kinematic Consistency: A Subgroup Analysis From a Randomized Clinical Trial

2009 ◽  
Vol 89 (8) ◽  
pp. 829-839 ◽  
Author(s):  
Michael D. Lewek ◽  
Theresa H. Cruz ◽  
Jennifer L. Moore ◽  
Heidi R. Roth ◽  
Yasin Y. Dhaher ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Small Sample Size ◽  
Gait Pattern ◽  
Small Sample ◽  
Lower Limbs ◽  
Walking Ability ◽  
Locomotor Training ◽  
Robotic Assisted ◽  
Robotic Devices

BackgroundLocomotor training (LT) to improve walking ability in people poststroke can be accomplished with therapist assistance as needed to promote continuous stepping. Various robotic devices also have been developed that can guide the lower limbs through a kinematically consistent gait pattern. It is unclear whether LT with either therapist or robotic assistance could improve kinematic coordination patterns during walking.ObjectiveThe purpose of this study was to determine whether LT with physical assistance as needed was superior to guided, symmetrical, robotic-assisted LT for improving kinematic coordination during walking poststroke.DesignThis study was a randomized clinical trial.MethodsNineteen people with chronic stroke (&gt;6 months’ duration) participating in a larger randomized control trial comparing therapist- versus robotic-assisted LT were recruited. Prior to and following 4 weeks of LT, gait analysis was performed at each participant's self-selected speed during overground walking. Kinematic coordination was defined as the consistency of intralimb hip and knee angular trajectories over repeated gait cycles and was compared before and after treatment for each group.ResultsLocomotor training with therapist assistance resulted in significant improvements in the consistency of intralimb movements of the impaired limb. Providing consistent kinematic assistance during robotic-assisted LT did not result in improvements in intralimb consistency. Only minimal changes in discrete kinematics were observed in either group.LimitationsThe limitations included a relatively small sample size and a lack of quantification regarding the extent of movement consistency during training sessions for both groups.ConclusionsCoordination of intralimb kinematics appears to improve in response to LT with therapist assistance as needed. Fixed assistance, as provided by this form of robotic guidance during LT, however, did not alter intralimb coordination.

scholarly journals Comparison of Two Different Ozone Injection Sites for Knee Osteoarthritis, Tibio-femoral Joint versus Supra-patellar Recess: An Open Randomized Clinical Trial

2020 ◽  
pp. 37-49
Author(s):  
Masoud Hashemi ◽  
Mehrdad Taheri ◽  
Payman Dadkhah ◽  
Hasti Hassani ◽  
Mohammadhossein Ataie ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Knee Osteoarthritis ◽  
Pain Score ◽  
Outcome Measures ◽  
Secondary Outcome ◽  
Womac Pain ◽  
Joint Injection ◽  
Knee Oa ◽  
Ozone Injection

Background: The aim of this study was to compare the efficacy of ozone injection at Tibio-femoral joint with Supra-patellar recess on knee osteoarthritis (OA). Methods: In this randomized, controlled clinical trial, 99 patients with symptomatic knee OA were randomized into two groups. 47 patients selected to receive 7-8 ml ozone (20 µg/ml) through Tibio-femoral joint injection, and 49 patients received 10 ml ozone (20 µg/ml) through supra-patellar recess injection by using in-plane ultrasound-guided. The primary outcome was the change from baseline in the visual analogue scale (VAS) (0-100 mm) pain score during 3 months after injection. Secondary outcome measures included the Western Ontario and McMaster universities OA Index (WOMAC), Lequesne index, time “Up and Go” (TUG) test, single-limb stance (SLS) tests, patient satisfaction, and adverse effects. All of these measurements were evaluated at the base time, 48 hours, 2 weeks, 1 month, 2 months, and 3 months after injection. Results: Both groups had significantly improvement in the primary and secondary outcome measures. VAS pain score except at the 3–month follow-up (16.8±13.3 versus 18.1±16.6, 95% CI, -7.33 to 4.73, p =0.6), WOMAC pain score, WOMAC stiffness score at all evaluated times, and WOMAC total score at 48 hours after injection (95% CI, -19.4 to -4.9) were significantly better among Tibio-femoral ozone injection compare to Supra-patellar recess injection (95% CI, -20.68 to -6.51, p<0.001)). In both groups satisfaction, TUG and SLS times were improved, but no significant difference was seen between groups (p>0.05). At the 3-month follow-up, WOMAC pain and total scores for only Tibio-femoral joint injection group as well as WOMAC function, TUG and SLS times for both groups were gradually coming back to the baseline. Conclusion: Ozone injection in both groups was associated with pain relief, functional improvement, and quality of life in patient with knee OA. Pain and stiffness of joint were improved better in Supra-patellar recess ozone injection.

scholarly journals Effect of Virtual Reality Gait Training on Participation in Survivors of Subacute Stroke: Randomized Controlled Trial

2021 ◽  
Author(s):  
Ilona J M de Rooij ◽  
Ingrid G L van de Port ◽  
Michiel Punt ◽  
Pim J M Abbink-van Moorsel ◽  
Michiel Kortsmit ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Virtual Reality ◽  
Controlled Trial ◽  
Gait Training ◽  
Secondary Outcome ◽  
Community Living ◽  
Walking Ability ◽  
Randomized Controlled ◽  
Subacute Stroke ◽  
Walking Activity

Abstract Objective After stroke, people experience difficulties with walking that lead to restrictions in participation in daily life. The purpose of this study was to examine the effect of virtual reality gait training (VRT) compared to non-virtual reality gait training (non-VRT) on participation in community-living people after stroke. Methods In this assessor-blinded randomized controlled trial with 2 parallel groups, people were included between 2 weeks and 6 months after stroke and randomly assigned to the VRT group or non-VRT group. Participants assigned to the VRT group received training on the Gait Real-time Analysis Interactive Lab (GRAIL), and participants assigned to the non-VRT group received treadmill training and functional gait exercises without virtual reality. Both training interventions consisted of 12 30-minute sessions during 6 weeks. Primary outcome was participation measured with the restrictions subscale of the Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P) 3 months postintervention. Secondary outcomes included subjective physical functioning, functional mobility, walking ability, dynamic balance, walking activity, fatigue, anxiety and depression, falls efficacy, and quality of life. Results Twenty-eight participants were randomized to the VRT group and 27 to the non-VRT group, of which 25 and 22 attended 75% or more of the training sessions, respectively. No significant differences between the groups were found over time for the USER-P restrictions subscale (1.23; 95% CI = −0.76 to 3.23) or secondary outcome measures. Patients’ experiences with VRT were positive, and no serious adverse events were related to the interventions. Conclusions The effect of VRT was not statistically different from non-VRT in improving participation in community-living people after stroke. Impact Although outcomes were not statistically different, treadmill-based VRT was a safe and well-tolerated intervention that was positively rated by people after stroke. VR training might, therefore, be a valuable addition to stroke rehabilitation.

Convergence Insufficiency Treatment Trial – Attention and Reading Trial (CITT-ART): Design and Methods

2015 ◽  
pp. 214-228 ◽  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Health Care Providers ◽  
Developmental Disorders ◽  
Attention Problems ◽  
Secondary Outcome ◽  
Care Providers ◽  
Treatment Trial ◽  
Additional Hypothesis ◽  
Convergence Insufficiency

Objective: To describe the design and methodology of the Convergence Insufficiency Treatment Trial: Attention and Reading Trial (CITT-ART), the first randomized clinical trial evaluating the effect of vision therapy on reading and attention in school-age children with symptomatic convergence insufficiency (CI). Methods: CITT-ART is a multicenter, placebo-controlled, randomized clinical trial of 324 children ages 9 to 14 years in grades 3 to 8 with symptomatic CI. Participants are randomized to 16 weeks of office-based vergence/accommodative therapy (OBVAT) or placebo therapy (OBPT), both supplemented with home therapy. The primary outcome measure is the change in the Wechsler Individual Achievement Test-Version 3 (WIAT-III) reading comprehension subtest score. Secondary outcome measures are changes in attention as measured by the Strengths and Weaknesses of Attention (SWAN) as reported by parents and teachers, tests of binocular visual function, and other measures of reading and attention. The long-term effects of treatment are assessed 1 year after treatment completion. All analyses will test the null hypothesis of no difference in outcomes between the two treatment groups. The study is entering its second year of recruitment. The final results will contribute to a better understanding of the relationship between the treatment of symptomatic CI and its effect on reading and attention. Conclusion: The study will provide an evidence base to help parents, eye professionals, educators, and other health care providers make informed decisions as they care for children with CI and reading and attention problems. Results may also generate additional hypothesis and guide the development of other scientific investigations of the relationships between visual disorders and other developmental disorders in children.

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