scholarly journals Effects of Lower Extremities Constraint Induced Movement Therapy on Gait and Balance of Chronic Hemiparetic Patients After Stroke: Description of a Study Protocol for a Randomized Controlled Clinical Trial.

2021 ◽  
Author(s):  
Elaine Menezes Oliveira ◽  
Gabriela da Silva Matuti ◽  
Clarissa Barros de Oliveira ◽  
Simone Ferreira de Freitas ◽  
Catia Miyuki Kawamura ◽  
...  
Keyword(s):  
Repeated Measures ◽  
Chronic Phase ◽  
Lower Extremities ◽  
Movement Therapy ◽  
Clinical Event ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Walk Test ◽  
Randomized Controlled ◽  
Constraint Induced Movement Therapy

Abstract BackgroundProtocols involving intensive practice have shown positive outcomes. Constraint Induced Movement Therapy (CIT) appears to be one of the best options for better outcomes in upper limb rehabilitation, but we still have little data about Lower Extremities - Constraint Induced Movement Therapy (LE-CIT) and its effects on gait and balance.ObjectiveTo evaluate the effects of an LE-CIT protocol on gait functionality and balance in chronic hemiparetic patients following a stroke.MethodsThe study adopts a randomized, controlled, single-blinded study design. 42 patients who suffered a stroke event, in the chronic phase of recovery (>6 months), with gait disability (no community gait), able to walk at least 10 meters with or without the advice or support of 1 person, will be randomly allocated to 2 groups: the LE-CIT Group or the Control Group (Intensive Conventional Therapy). People will be excluded if they have speech deficits that render them unable to understand and/or answer properly to evaluation scales and exercises selected for the protocol and/or if they have suffered any clinical event between the screening and the beginning of the protocol. Outcome will be assessed at baseline (T0), immediately after the intervention (T1), and after 6 months (T2). The outcome measures chosen for this trial are: 6 minute walk test (6minWT), 10 meter walk test (10mWT), Timed Up and Go (TUG), 3-D gait analysis (3DGA), Mini Balance Evaluation Systems Test (Mini-BESTest) and, as a secondary measure, Lower Extremity Motor Activity Log will be evaluated (LE-MAL). The participants in both groups will receive 15 followed days of daily exercise. The participants in the LE-CIT Group will be submitted to this protocol 2.5 hour/day for 15 followed days. It will include: 1) intensive supervised training, 2) use of shaping as strategy for motor training, and 3) application of a transfer package (plus 30 minutes). The Control Group will receive conventional physiotherapy for 2.5 hours/day over 15 followed days (the same period as the CIT intervention). Repeated measures analyses will be made to compare differences and define clinically relevant changes between groups.ResultsData collection is currently on-going and results are expected in 2021.Discussion: LE-CIT seems to be a good protocol for inclusion into stroke survivors’ rehabilitation as it has all the components needed for positive results, as well as intensity and transference of gains to daily life activities.Trial Registration: www.ensaiosclinicos.gov.br (Register Number: RBR-467cv6). Date of registration: October 10, 2017. “Effects of Lower Extremities - Constraint Induced Therapy on gait and balance function in chronic hemipretic post-stroke patients”.

scholarly journals Effects of lower extremity constraint-induced movement therapy on gait and balance of chronic hemiparetic patients after stroke: description of a study protocol for a randomized controlled clinical trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Elaine Menezes-Oliveira ◽  
Gabriela da Silva Matuti ◽  
Clarissa Barros de Oliveira ◽  
Simone Ferreira de Freitas ◽  
Catia Miyuki Kawamura ◽  
...  
Keyword(s):  
Lower Extremity ◽  
Repeated Measures ◽  
Chronic Phase ◽  
Movement Therapy ◽  
Clinical Event ◽  
Control Group ◽  
Walk Test ◽  
Randomized Controlled ◽  
Link Type ◽  
Constraint Induced Movement Therapy

Abstract Background Protocols involving intensive practice have shown positive outcomes. Constraint induced movement therapy (CIT) appears to be one of the best options for better outcomes in upper limb rehabilitation, but we still have little data about lower extremity constraint-induced movement therapy (LE-CIT) and its effects on gait and balance. Objective To evaluate the effects of an LE-CIT protocol on gait functionality and balance in chronic hemiparetic patients following a stroke. Methods The study adopts a randomized, controlled, single-blinded study design. Forty-two patients, who suffered a stroke, who were in the chronic phase of recovery (>6 months), with gait disability (no community gait), and who were able to walk at least 10 m with or without the advice or support of 1 person, will be randomly allocated to 2 groups: the LE-CIT group or the control group (intensive conventional therapy). People will be excluded if they have speech deficits that render them unable to understand and/or answer properly to evaluation scales and exercises selected for the protocol and/or if they have suffered any clinical event between the screening and the beginning of the protocol. Outcome will be assessed at baseline (T0), immediately after the intervention (T1), and after 6 months (T2). The outcome measures chosen for this trial are as follows: 6-min walk test (6minWT), 10-m walk test (10mWT), timed up and go (TUG), 3-D gait analysis (3DGA), Mini Balance Evaluation Systems Test (Mini-BESTest), and as a secondary measure, Lower Extremity Motor Activity Log will be evaluated (LE-MAL). The participants in both groups will receive 15 consecutive days of daily exercise. The participants in the LE-CIT group will be submitted to this protocol 2.5 h/day for 15 consecutive days. It will include (1) intensive supervised training, (2) use of shaping as strategy for motor training, and (3) application of a transfer package (plus 30 min). The control group will receive conventional physiotherapy for 2.5 h/day over 15 consecutive days (the same period as the CIT intervention). Repeated measures analyses will be made to compare differences and define clinically relevant changes between groups. Results Data collection is currently on-going and results are expected in 2021. Discussion LE-CIT seems to be a good protocol for inclusion into stroke survivors’ rehabilitation as it has all the components needed for positive results, as well as intensity and transference of gains to daily life activities. Trial registration www.ensaiosclinicos.gov.brRBR-467cv6. Registered on 10 October 2017. “Effects of Lower Extremities - Constraint Induced Therapy on gait and balance function in chronic hemipretic post-stroke patients”.

scholarly journals Effectiveness of Abdominal and Gluteus Medius Training in Lumbo-Pelvic Stability and Adductor Strength in Female Soccer Players. A Randomized Controlled Study

2021 ◽  
Vol 18 (4) ◽  
pp. 1528
Author(s):  
Héctor Guerrero-Tapia ◽  
Rodrigo Martín-Baeza ◽  
Rubén Cuesta-Barriuso
Keyword(s):  
Repeated Measures ◽  
Gluteus Medius ◽  
Soccer Players ◽  
Controlled Study ◽  
Control Group ◽  
Extrinsic Factors ◽  
Randomized Controlled ◽  
Limb Injuries ◽  
Experimental Group

Background. Abdominal and lumbo-pelvic stability alterations may be the origin of lower limb injuries, such as adductor pathology in soccer players. Imbalance can be caused by both intrinsic and extrinsic factors. Methods: In this randomized controlled trial over 8 weeks, 25 female footballers were randomly allocated to an experimental group (isometric abdominal training and gluteus medius-specific training) or a control group (isometric abdominal training). Evaluations were performed at baseline, at the end of the intervention and after a 4-week follow-up period. The exercise protocol in common for both groups included three exercises: Plank, Lateral plank and Bird dog. Specific exercises for the gluteus medius were: Pelvic drop and Stabilization of the gluteus medius in knee valgus. Outcome measures were lumbar-pelvic stability and adductor strength. Results: After the intervention, there was an increase in lumbo-pelvic stability in both groups, being greater in the control group than in the experimental group (mean differences [MD]: 4.84 vs. MD: 9.58; p < 0.01) with differences in the analysis of repeated measures (p < 0.001), but not in group interaction (p = 0.26). Changes were found in adductor strength in the experimental group (MD: −2.48; p < 0.001 in the left adductor; MD: −1.48; p < 0.01 in right adductor) and control group (MD: −1.68; p < 0.001 in the left adductor; MD: −2.05; p < 0.001 in the right adductor) after the intervention, with differences in the analysis of repeated measures in left (p < 0.001) and right (p < 0.001) adductor strength. Conclusions: An abdominal and gluteal training protocol shows no advantage over a protocol of abdominal training alone for lumbo-pelvic stability and adductor strength, while improvements in both variables are maintained at four weeks follow-up.

scholarly journals Robot-Assisted Gait Training in Patients with Multiple Sclerosis: A Randomized Controlled Crossover Trial

Medicina ◽  
2021 ◽  
Vol 57 (7) ◽  
pp. 713
Author(s):  
Cristiano Sconza ◽  
Francesco Negrini ◽  
Berardo Di Matteo ◽  
Alberto Borboni ◽  
Gennaro Boccia ◽  
...  
Keyword(s):  
Crossover Trial ◽  
Gait Training ◽  
Treatment Session ◽  
Control Group ◽  
Walk Test ◽  
Robot Assisted ◽  
Randomized Controlled ◽  
Gait Parameters ◽  
Before And After

Background and Objectives: Gait disorders represent one of the most disabling aspects in multiple sclerosis (MS) that strongly influence patient quality of life. The improvement of walking ability is a primary goal for rehabilitation treatment. The aim of this study is to evaluate the effectiveness of robot-assisted gait training (RAGT) in association with physiotherapy treatment in patients affected by MS in comparison with ground conventional gait training. Study design: Randomized controlled crossover trial. Materials and Methods: Twenty-seven participants affected by MS with EDSS scores between 3.5 and 7 were enrolled, of whom seventeen completed the study. They received five training sessions per week over five weeks of conventional gait training with (experimental group) or without (control group) the inclusion of RAGT. The patients were prospectively evaluated before and after the first treatment session and, after the crossover phase, before and after the second treatment session. The evaluation was based on the 25-foot walk test (25FW, main outcome), 6 min walk test (6MWT), Tinetti Test, Modified Ashworth Scale, and modified Motricity Index for lower limbs. We also measured disability parameters using Functional Independence Measure and Quality of Life Index, and instrumental kinematic and gait parameters: knee extensor strength, double-time support, step length ratio; 17 patients reached the final evaluation. Results: Both groups significantly improved on gait parameters, motor abilities, and autonomy recovery in daily living activities with generally better results of RAGT over control treatment. In particular, the RAGT group improved more than control group in the 25FW (p = 0.004) and the 6MWT (p = 0.022). Conclusions: RAGT is a valid treatment option that in association with physiotherapy could induce positive effects in MS-correlated gait disorders. Our results showed greater effectiveness in recovering gait speed and resistance than conventional gait training.

scholarly journals Benefits of Dog-Assisted Therapy in Patients with Dementia Residing in Aged Care Centers in Spain

2021 ◽  
Vol 18 (4) ◽  
pp. 1471
Author(s):  
Eva Vegue Parra ◽  
Jose Manuel Hernández Garre ◽  
Paloma Echevarría Pérez
Keyword(s):  
Scientific Evidence ◽  
Alternative Therapy ◽  
Group Versus ◽  
Aged Care ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Neuropsychiatric Inventory ◽  
Randomized Controlled ◽  
Institutionalized Patients ◽  
Experimental Group

(1) Background: Currently, the scientific evidence on the benefits of assisted therapy with dogs in dementia is not clear. In this study, we want to evaluate such benefits through a randomized controlled clinical trial in multiple centers across the country. (2) Methods: The participants were people over 65 years old with dementia, residing in senior centers in Spain (n = 334). The experimental group underwent assisted therapy with dogs based on the Comprehensive Cognitive Activation Program in Dementia, for 8 months, with weekly sessions of 45 min. Data were collected at the commencement, middle, and end of the program, to evaluate the aspects using the Mini-Examination Cognitive, the modified Bartell Index, the Cornell Scale for Depression in Dementia and the Neuropsychiatric Inventory. (3) Results: The results show significant improvements in the experimental group versus the control group in the affective (T1 = p 0.000; T2 = p 0.000) and behavioral (T1 = p 0.005; T2 = p 0.000) aspects, with the affective aspect displaying greater progress in participants with additional depressive (p = 0.022) or anxiety (p = 0.000) disorders, shorter institutionalization periods (r = −0.222, p = 0.004), and those undergoing complementary psychotherapy (p = 0.033) or alternative therapy (p = 0.011). (4) Conclusions: Dog therapy is effective in improving the affective and behavioral aspects of institutionalized patients with dementia.

Effects of Calisthenics and Pilates Exercises on Coordination and Proprioception in Adult Women: A Randomized Controlled Trial

2012 ◽  
Vol 21 (3) ◽  
pp. 235-243 ◽  
Author(s):  
Derya Ozer Kaya ◽  
Irem Duzgun ◽  
Gul Baltaci ◽  
Selma Karacan ◽  
Filiz Colakoglu
Keyword(s):  
Outcome Measures ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Exercise Group ◽  
Lower Limbs ◽  
Control Group ◽  
Adult Women ◽  
Kinetic Chain ◽  
Randomized Controlled ◽  
Closed Kinetic Chain

Objective:To assess and compare the effects of 6 mo of Pilates and calisthenics on multijoint coordination and proprioception of the lower limbs at the 3rd and 6th mo of training.Design:Randomized, controlled, assessor-blinded, repeated-measures.Setting:University research laboratory.Participants and Intervention:Healthy, sedentary, female participants age 25–50 y were recruited and randomly divided into 3 groups: a calisthenic exercise group (n = 34, mean age ± SD 40 ± 8 y, body-mass index [BMI] 31.04 ± 4.83 kg/m2), a Pilates exercise group (n = 32, mean age ± SD 37 ± 8 y, BMI 31.04 ± 4.83 kg/m2), and a control group (n = 41, mean age ± SD 41 ± 7 y, BMI 27.09 ± 4.77 kg/m2). The calisthenics and Pilates groups underwent related training programs for 6 mo, while the controls had no specific training.Main Outcome Measures:Coordination and proprioception of the lower extremities with concentric and eccentric performances in the closed kinetic chain assessed with the monitored rehab functional squat system at baseline and at the 3rd and 6th mo of training.Results:For the within-group comparison, coordinative concentric and eccentric deviation values were significantly decreased for both dominant and nondominant lower limbs at pretraining and at the 3rd and 6th mo posttraining in the calisthenics group (P < .05). In contrast, there was no improvement in the Pilates group throughout the training. However, for comparisons between groups, the baseline values of coordinative concentric and eccentric deviations were different in the calisthenics group than in Pilates and the controls (P < .05). There were no differences in the proprioception values of either visible or nonvisible movement in any group throughout the training (P > .05).Conclusions:It seems that calisthenic exercises are more likely to improve coordination of the lower extremity after 3 and 6 mo of training than Pilates exercises. Calisthenic exercises may be useful for individuals who require improved coordination.

scholarly journals A randomized controlled clinical trial of the effect of supportive counseling on mental health in Iranian mothers of premature infants

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Leila Seiiedi-Biarag ◽  
Mojgan Mirghafourvand ◽  
Khalil Esmaeilpour ◽  
Shirin Hasanpour
Keyword(s):  
Mental Health ◽  
Clinical Trial ◽  
Premature Infants ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Postpartum Bonding ◽  
Supportive Counseling

Abstract Background Premature birth can affect maternal mental health. Considering that the mental health disorder in mothers may play a vital role in the growth and development of their children, therefore, this study was conducted to determine the effect of supportive counseling on mental health (primary outcome), mother-child bonding and infant anthropometric indices (secondary outcomes) in mothers of premature infants. Methods This randomized controlled clinical trial was carried out on 66 mothers with hospitalized neonates in the NICU of Alzahra hospital in Tabriz- Iran. Participants were randomly allocated into two groups of intervention (n = 34) and control (n = 32) through a block randomization method. The intervention group received 6 sessions of supportive counseling (45–60 minutes each session) by the researcher, and the control group received routine care. Questionnaires of Goldberg General Health and the postpartum bonding were completed before the intervention (first 72 hours postpartum) and 8 weeks postpartum. Also, the anthropometric index of newborns were measured at the same time. Results There was no statistically significant difference between the two groups in terms of socio-demographic characteristics. After the intervention, based on ANCOVA with adjusting the baseline score, mean score of mental health (AMD: -9.8; 95% Confident Interval (95% CI): -12.5 to -7.1; P < 0.001) and postpartum bonding (AMD: -10.0; 95% CI: -0.6 to 13.9; P < 0.001) in the counseling group was significantly lower than those of the control group; however, in terms of weight (P = 0.536), height (P = 0.429) and head circumference (P = 0.129), there was no significant difference between the two groups. Conclusions Supportive counseling may improve mental health and postpartum bonding in mothers of premature infants. Thus, it may be recommendable for health care providers to offer it to mothers. Trial registration Iranian Registry of Clinical Trials (IRCT): IRCT20120718010324N45. Date of registration: October 29, 2018.

scholarly journals Supragingival plaque removal with and without dentifrice: a randomized controlled clinical trial

2012 ◽  
Vol 23 (3) ◽  
pp. 235-240 ◽  
Author(s):  
Fabricio B. Zanatta ◽  
Raquel P. Antoniazzi ◽  
Tatiana M. P. Pinto ◽  
Cassiano K. Rösing
Keyword(s):  
Clinical Trial ◽  
Test Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Separate Analysis ◽  
Randomized Controlled Clinical Trial ◽  
Significance Level ◽  
Plaque Removal ◽  
Randomized Controlled ◽  
Removal Capacity

The aim of this study was to compare the efficacy of dental plaque removal by brushing with and without conventional dentifrice. Twenty-four students aged 17 to 28 years participated in this randomized controlled clinical trial. Quadrants 1-3 or 2-4 were randomly allocated to the test group (brushing without dentifrice) or control group (brushing with dentifrice). After 72 h of cessation of oral hygiene, Quigley & Hein (Turesky) plaque index was assessed before and after brushing by a calibrated and blind examiner. Overtime and intergroup comparisons were performed by Student's paired sample t-test at 5% significance level. The results showed that both groups after toothbrushing presented statistically significant reductions in plaque, with no differences between them (from 3.06 ± 0.54 to 1.27 ± 0.26 versus from 3.07 ± 0.52 to 1.31 ± 0.23). A separate analysis of the buccal and lingual aspects also showed no significant differences between groups. It may be concluded that the use of a conventional dentifrice during toothbrushing does not seem to enhance plaque removal capacity.

Effects of constraint-induced movement therapy for lower limbs on measurements of functional mobility and postural balance in subjects with stroke: a randomized controlled trial

2017 ◽  
Vol 24 (8) ◽  
pp. 555-561 ◽  
Author(s):  
Emília Márcia Gomes de Souza e Silva ◽  
Tatiana Souza Ribeiro ◽  
Tállyta Camyla Chaves da Silva ◽  
Mayara Fabiana Pereira Costa ◽  
Fabrícia Azevedo da Costa Cavalcanti ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Postural Balance ◽  
Controlled Trial ◽  
Movement Therapy ◽  
Functional Mobility ◽  
Lower Limbs ◽  
Randomized Controlled ◽  
Constraint Induced Movement Therapy

scholarly journals App Technology to Support Physical Activity and Intake of Vitamins and Minerals After Bariatric Surgery (the PromMera Study): Protocol of a Randomized Controlled Clinical Trial (Preprint)

2020 ◽  
Author(s):  
Stephanie Erika Bonn ◽  
Mari Hult ◽  
Kristina Spetz ◽  
Marie Löf ◽  
Ellen Andersson ◽  
...  
Keyword(s):  
Physical Activity ◽  
Bariatric Surgery ◽  
Controlled Trial ◽  
Intervention Group ◽  
Study Participant ◽  
Lifestyle Factors ◽  
Lifestyle Changes ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled

BACKGROUND To optimize postoperative outcomes after bariatric surgery, lifestyle changes including increased physical activity are needed. Micronutrient deficiency after surgery is also common and daily supplementation is recommended. OBJECTIVE The aim of the PromMera study is to evaluate the effects of a 12-week smartphone app intervention on promotion of physical activity (primary outcome) and adherence to postsurgery vitamin and mineral supplementation, as well as on other lifestyle factors and overall health in patients undergoing bariatric surgery. METHODS The PromMera study is a two-arm, randomized controlled trial comprising patients undergoing bariatric surgery. Participants are randomized postsurgery 1:1 to either the intervention group (ie, use of the PromMera app for 12 weeks) or the control group receiving only standard care. Clinical and lifestyle variables are assessed pre- and postsurgery after 18 weeks (postintervention assessment), 6 months, 1 year, and 2 years. Assessments include body composition using Tanita or BOD POD analyzers, muscle function using handgrip, biomarkers in blood, and an extensive questionnaire on lifestyle factors. Physical activity is objectively measured using the ActiGraph wGT3X-BT triaxial accelerometer. RESULTS A total of 154 participants have been enrolled in the study. The last study participant was recruited in May 2019. Data collection will be complete in May 2021. CONCLUSIONS Implementing lifestyle changes are crucial after bariatric surgery and new ways to reach patients and support such changes are needed. An app-based intervention is easily delivered at any time and can be a key factor in the adoption of healthier behavioral patterns in this rapidly growing group of patients. CLINICALTRIAL ClinicalTrials.gov NCT03480464; https://clinicaltrials.gov/ct2/show/NCT03480464 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/19624

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