scholarly journals The doll therapy as a first line treatment for behavioral and psychologic symptoms of dementia in nursing homes residents: a randomized, controlled study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Francesca Santagata ◽  
Massimiliano Massaia ◽  
Patrizia D’Amelio
Keyword(s):  
Nursing Homes ◽  
Caregiver Burden ◽  
Controlled Trial ◽  
Nursing Home Residents ◽  
Assessment Method ◽  
Trial Registration ◽  
Controlled Study ◽  
First Line ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Patients living with dementia are severely affected by the development of behavioral and psychologic symptoms (BPSD) which represent a burden for patients and caregivers. The use of psychotropic drugs in the control of BPSD is widely diffused, however the use of a first line non-pharmacologic approach is highly recommended. Here we evaluate the effect of doll therapy (DT) in the management of BPSD, on the reduction of caregiver burden and delirium incidence in nursing home residents by a randomized controlled trial. Methods We enrolled fifty-two nursing homes residents living with dementia and BPSD. Subjects were randomized to DT (26) or standard treatment (ST, 26), we measured BPSD, caregiver burden and delirium with standard clinical scales at baseline, after 45 and 90 days. In order to evaluate the presence of BPSD we used Neuropsychiatric Inventory (NPI) scale and the A.Di.CO scale, the caregiver burden was measured by the Greutzner scale and delirium by the Confusion Assessment Method (CAM) scale. Results DT was more effective in reducing agitation and aggressiveness as respect to ST. Moreover DT globally reduced the presence of BPSD as dysphoria, wandering and apathy. We observed a significant reduction of the professional caregiver burden and the incidence of delirium was significantly reduced in subjects treated with DT. Conclusions We show that DT is more effective that ST in the control of BSPD in patients affected by moderate to severe dementia. Moreover we suggest that DT may effective in reducing the incidence of delirium. Trial registration Retrospectively registered in ClinicalTrials.gov the 10th June 2, 2021 trial registration number NCT04920591.

scholarly journals The Doll Therapy as a First Line Treatment for Behavioral and Psychologic Symptoms of Dementia in Nursing Homes Residents: A Randomized, Controlled Study

2021 ◽  
Author(s):  
Francesca Santagata ◽  
Massimiliano Massaia ◽  
Patrizia D'amelio
Keyword(s):  
Nursing Homes ◽  
Caregiver Burden ◽  
Nursing Home Residents ◽  
Confusion Assessment Method ◽  
Assessment Method ◽  
Controlled Study ◽  
First Line ◽  
Clinical Scales ◽  
Randomized Controlled ◽  
Registration Number

Abstract Background. Patients affected by dementia are severely affected by the development of behavioral and psychologic symptoms (BPSD) which represent a burden for patients and caregivers. The use of psychotropic drugs in the control of BPSD is widely diffused, however the use of a first line non-pharmacologic approach is highly recommended. Here we evaluate the effect of doll therapy (DT) in the management of BPSD, on the reduction of caregiver burden and delirium incidence in nursing home residents by a randomized controlled trial.Methods. We enrolled fifty-two nursing homes residents living with dementia and BPSD. Subjects were randomized to DT (26) or standard treatment (ST, 26), we measured BPSD, caregiver burden and delirium with standard clinical scales at baseline, after 45 and 90 days. In order to evaluate the presence of BPSD we used Neuropsychiatric Inventory (NPI) scale and the A.Di.CO scale, the caregiver burden was measured by the Greutzner scale and delirium by the Confusion Assessment Method (CAM) scale.Results. DT was more effective in reducing agitation and aggressiveness as respect to ST. Moreover DT globally reduced the presence of BPSD as dysphoria, wandering and apathy. We observed a significant reduction of the professional caregiver burden and the incidence of delirium was significantly reduced in subjects treated with DT.Conclusions. We show that DT is more effective that ST in the control of BSPD in patients affected by moderate to severe dementia. Moreover we suggest that DT may effective in reducing the incidence of delirium.Trial Registration: Retrospectively registered in ClinicalTrials.gov the 02nd June 2, 2021 trial registration number NCT04920591

scholarly journals A tablet-based intervention for activating nursing home residents with dementia: results from a cluster-randomized controlled trial

2021 ◽  
pp. 1-13
Author(s):  
Julie L. O’Sullivan ◽  
Sonia Lech ◽  
Paul Gellert ◽  
Ulrike Grittner ◽  
Jan-Niklas Voigt-Antons ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Nursing Home ◽  
Nursing Homes ◽  
Psychotropic Medication ◽  
Controlled Trial ◽  
Nursing Home Residents ◽  
Randomized Controlled ◽  
Cluster Randomized

Abstract Objectives: To investigate global and momentary effects of a tablet-based non-pharmacological intervention for nursing home residents living with dementia. Design: Cluster-randomized controlled trial. Setting: Ten nursing homes in Germany were randomly allocated to the tablet-based intervention (TBI, 5 units) or conventional activity sessions (CAS, 5 units). Participants: N = 162 residents with dementia. Intervention: Participants received regular TBI (n = 80) with stimulating activities developed to engage people with dementia or CAS (n = 82) for 8 weeks. Measurements: Apathy Evaluation Scale (AES-I, primary outcome), Quality of Life in Alzheimer’s Disease scale, QUALIDEM scale, Neuropsychiatric Inventory, Geriatric Depression Scale, and psychotropic medication (secondary outcomes). Momentary quality of life was assessed before and after each activity session. Participants and staff were blinded until the collection of baseline data was completed. Data were analyzed with linear mixed-effects models. Results: Levels of apathy decreased slightly in both groups (mean decrease in AES-I of .61 points, 95% CI −3.54, 2.33 for TBI and .36 points, 95% CI −3.27, 2.55 for CAS). Group difference in change of apathy was not statistically significant (β = .25; 95% CI 3.89, 4.38, p = .91). This corresponds to a standardized effect size (Cohen’s d) of .02. A reduction of psychotropic medication was found for TBI compared to CAS. Further analyses revealed a post-intervention improvement in QUALIDEM scores across both groups and short-term improvements of momentary quality of life in the CAS group. Conclusions: Our findings suggest that interventions involving tailored activities have a beneficial impact on global and momentary quality of life in nursing home residents with dementia. Although we found no clear advantage of TBI compared to CAS, tablet computers can support delivery of non-pharmacological interventions in nursing homes and facilitate regular assessments of fluctuating momentary states.

scholarly journals Prophylactic Melatonin for Delirium in Intensive Care (Pro-MEDIC): study protocol for a randomised controlled trial

Trials ◽  
2017 ◽  
Vol 18 (1) ◽  
Author(s):  
F. Eduardo Martinez ◽  
Matthew Anstey ◽  
Andrew Ford ◽  
Brigit Roberts ◽  
Miranda Hardie ◽  
...  
Keyword(s):  
Intensive Care ◽  
Critically Ill ◽  
Controlled Trial ◽  
Study Drug ◽  
Assessment Method ◽  
Trial Registration ◽  
Morbidity And Mortality ◽  
Controlled Study ◽  
Clinical Trial Registry ◽  
Icu Discharge

Abstract Background Delirium is an acute state of brain dysfunction characterised by fluctuating inattention and cognitive disturbances, usually due to illness. It occurs commonly in the intensive care unit (ICU), and it is associated with greater morbidity and mortality. It is likely that disturbances of sleep and of the day-night cycle play a significant role. Melatonin is a naturally occurring, safe and cheap hormone that can be administered to improve sleep. The main aim of this trial will be to determine whether prophylactic melatonin administered to critically ill adults, when compared with placebo, decreases the rate of delirium. Methods This trial will be a multi-centre, randomised, placebo-controlled study conducted in closed ICUs in Australia. Our aim is to enrol 850 adult patients with an expected ICU length of stay (LOS) of 72 h or more. Eligible patients for whom there is consent will be randomised to receive melatonin 4 mg enterally or placebo in a 1:1 ratio according to a computer-generated randomisation list, stratified by site. The study drug will be indistinguishable from placebo. Patients, doctors, nurses, investigators and statisticians will be blinded. Melatonin or placebo will be administered once per day at 21:00 until ICU discharge or 14 days after enrolment, whichever occurs first. Trained staff will assess patients twice daily to determine the presence or absence of delirium using the Confusion Assessment Method for the ICU score. Data will also be collected on demographics, the overall prevalence of delirium, duration and severity of delirium, sleep quality, participation in physiotherapy sessions, ICU and hospital LOS, morbidity and mortality, and healthcare costs. A subgroup of 100 patients will undergo polysomnographic testing to further evaluate the quality of sleep. Discussion Delirium is a significant issue in ICU because of its frequency and associated poorer outcomes. This trial will be the largest evaluation of melatonin as a prophylactic agent to prevent delirium in the critically ill population. This study will also provide one of the largest series of polysomnographic testing done in ICU. Trial registration Australian New Zealand Clinical Trial Registry (ANZCTR) number: ACTRN12616000436471. Registered on 20 December 2015.

scholarly journals Reducing Antibiotic Prescriptions for Urinary Tract Infection in Nursing Homes Using a Complex Tailored Intervention Targeting Nursing Home Staff: Protocol for a Cluster Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Sif Helene Arnold ◽  
Jette Nygaard Jensen ◽  
Marius Brostrøm Kousgaard ◽  
Volkert Siersma ◽  
Lars Bjerrum ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Nursing Home ◽  
Nursing Homes ◽  
Antibiotic Prescription ◽  
Controlled Trial ◽  
Nursing Home Residents ◽  
Cluster Randomized Controlled Trial ◽  
Nursing Home Staff ◽  
Randomized Controlled ◽  
Cluster Randomized

BACKGROUND Urinary tract infection (UTI) is the most common reason for antibiotic prescription in nursing homes. Overprescription causes antibiotic-related harms in those who are treated and others residing within the nursing home. The diagnostic process in nursing homes is complicated with both challenging issues related to the elderly population and the nursing home setting. A physician rarely visits a nursing home for suspected UTI. Consequently, the knowledge of UTI and communication skills of staff influence the diagnosis. OBJECTIVE The objective of this study is to describe a cluster randomized controlled trial with a tailored complex intervention for improving the knowledge of UTI and communication skills of nursing home staff in order to decrease the number of antibiotic prescriptions for UTI in nursing home residents, without changing hospitalization and mortality. METHODS The study describes an open-label cluster randomized controlled trial with two parallel groups and a 1:1 allocation ratio. Twenty-two eligible nursing homes are sampled from the Capital Region of Denmark, corresponding to 1274 nursing home residents. The intervention group receives a dialogue tool, and all nursing home staff attend a workshop on UTI. The main outcomes of the study are the antibiotic prescription rate for UTI, all-cause hospitalization, all-cause mortality, and suspected UTI during the trial period. RESULTS The trial ended in April 2019. Data have been collected and are being analyzed. We expect the results of the trial to be published in a peer-reviewed journal in the fall of 2020. CONCLUSIONS The greatest strengths of this study are the randomized design, tailored development of the intervention, and access to medical records. The potential limitations are the hierarchy in the prescription process, Hawthorne effect, and biased access to data on signs and symptoms through a UTI diary. The results of this trial could offer a strategy to overcome some of the challenges of increased antibiotic resistance and could have implications in terms of how to handle cases of suspected UTI. CLINICALTRIAL ClinicalTrials.gov NCT03715062; https://clinicaltrials.gov/ct2/show/NCT03715062 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/17710

scholarly journals Short-term versus 6-week prednisone in the treatment of subacute thyroiditis: a randomized controlled trial

2020 ◽  
Author(s):  
Lian Duan ◽  
Xiaoli Feng ◽  
Rui Zhang ◽  
Xiaojuan Tan ◽  
Xiaoyan Xiang ◽  
...  
Keyword(s):  
Side Effects ◽  
Thyroid Function ◽  
Subacute Thyroiditis ◽  
Trial Registration ◽  
Controlled Study ◽  
Short Term ◽  
Recurrence Rates ◽  
Randomized Controlled ◽  
Link Type ◽  
Secondary Endpoints

AbstractBackgroundModerate-to-severe subacute thyroiditis is commonly treated with 6-8 weeks glucocorticoids; however, no studies have described short-term prednisone treatment for subacute thyroiditis. We evaluated the efficacy of this treatment for subacute thyroiditis.MethodsThis was a 24-week, prospective, single-blind, randomized controlled study. Patients aged 18-70 years with subacute thyroiditis were hospitalized from August 2013 to December 2014. Patients with moderate-to-severe symptoms were randomized to receive either 30 mg/d prednisone for 1 week and then switched to 1 week of nonsteroidal anti-inflammatory drugs or 6 weeks of prednisone. The primary endpoints were the differences in efficacy at the end of treatment between two groups. Secondary endpoints included differences between the two groups in parameters of side effects at withdrawal and thyroid function at weeks 6, 12, 24.ResultsOf 96 patients screened, 52 subjects were randomized and 50 completed the study. Efficacy and recurrence rates were not significantly different at withdrawal in both groups (P=0.65). Parathyroid hormone (28.8 vs 38.9 pg/ml, p=0.011) and mean systolic blood pressure (113.9 vs 122.4 mmHg, p=0.023) were significantly lower in the experimental group than in the control group at discontinuation. No significant differences were observed in other secondary endpoints at withdrawal and in thyroid function at the 6th, 12th and 24th week during the follow-up time between the two groups.ConclusionsFewer side effects of glucocorticoids and similar efficacy and recurrence rates were observed with short-term prednisone compared with those with 6-week treatment for subacute thyroiditis. Short-term prednisone with a better safety profile may be as one alternative strategy for ameliorating moderate-to-severe symptoms of subacute thyroiditis.Trial registrationTrial registration number NCT01837433. Registered with Clinicaltrials.gov on 23 April 2013

scholarly journals Reducing Antibiotic Prescriptions for Urinary Tract Infection in Nursing Homes Using a Complex Tailored Intervention Targeting Nursing Home Staff: Protocol for a Cluster Randomized Controlled Trial

10.2196/17710 ◽  
2020 ◽  
Vol 9 (5) ◽  
pp. e17710 ◽  
Author(s):  
Sif Helene Arnold ◽  
Jette Nygaard Jensen ◽  
Marius Brostrøm Kousgaard ◽  
Volkert Siersma ◽  
Lars Bjerrum ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Nursing Home ◽  
Nursing Homes ◽  
Antibiotic Prescription ◽  
Controlled Trial ◽  
Nursing Home Residents ◽  
Cluster Randomized Controlled Trial ◽  
Nursing Home Staff ◽  
Randomized Controlled ◽  
Cluster Randomized

Background Urinary tract infection (UTI) is the most common reason for antibiotic prescription in nursing homes. Overprescription causes antibiotic-related harms in those who are treated and others residing within the nursing home. The diagnostic process in nursing homes is complicated with both challenging issues related to the elderly population and the nursing home setting. A physician rarely visits a nursing home for suspected UTI. Consequently, the knowledge of UTI and communication skills of staff influence the diagnosis. Objective The objective of this study is to describe a cluster randomized controlled trial with a tailored complex intervention for improving the knowledge of UTI and communication skills of nursing home staff in order to decrease the number of antibiotic prescriptions for UTI in nursing home residents, without changing hospitalization and mortality. Methods The study describes an open-label cluster randomized controlled trial with two parallel groups and a 1:1 allocation ratio. Twenty-two eligible nursing homes are sampled from the Capital Region of Denmark, corresponding to 1274 nursing home residents. The intervention group receives a dialogue tool, and all nursing home staff attend a workshop on UTI. The main outcomes of the study are the antibiotic prescription rate for UTI, all-cause hospitalization, all-cause mortality, and suspected UTI during the trial period. Results The trial ended in April 2019. Data have been collected and are being analyzed. We expect the results of the trial to be published in a peer-reviewed journal in the fall of 2020. Conclusions The greatest strengths of this study are the randomized design, tailored development of the intervention, and access to medical records. The potential limitations are the hierarchy in the prescription process, Hawthorne effect, and biased access to data on signs and symptoms through a UTI diary. The results of this trial could offer a strategy to overcome some of the challenges of increased antibiotic resistance and could have implications in terms of how to handle cases of suspected UTI. Trial Registration ClinicalTrials.gov NCT03715062; https://clinicaltrials.gov/ct2/show/NCT03715062 International Registered Report Identifier (IRRID) DERR1-10.2196/17710

scholarly journals Evaluating a web- and telephone-based personalised exercise intervention for individuals living with metastatic prostate cancer (ExerciseGuide): protocol for a pilot randomised controlled trial

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Holly E. L. Evans ◽  
Cynthia C. Forbes ◽  
Daniel A. Galvão ◽  
Corneel Vandelanotte ◽  
Robert U. Newton ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Metastatic Prostate Cancer ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Behavioural Change ◽  
Trial Registration ◽  
Controlled Study ◽  
Link Type ◽  
Supervised Exercise ◽  
Randomised Controlled

Abstract Introduction Preliminary research has shown the effectiveness of supervised exercise-based interventions in alleviating sequela resulting from metastatic prostate cancer. Despite this, many individuals do not engage in sufficient exercise to gain the benefits. There are many barriers, which limit the uptake of face-to-face exercise in this population including lack of suitable facilities, remoteness, and access to experts, significant fatigue, urinary incontinence and motivation. Technology-enabled interventions offer a distance-based alternative. This protocol describes a pilot two-armed randomised controlled study that will investigate the feasibility and preliminary efficacy of an online exercise and behavioural change tool (ExerciseGuide) amongst individuals with metastatic prostate cancer. Methods Sixty-six participants with histologically diagnosed metastatic prostate cancer will be randomised into either the 8-week intervention or a wait-list control. The intervention arm will have access to a tailored website, remote supervision, and tele-coaching sessions to enhance support and adherence. Algorithms will individually prescribe resistance and aerobic exercise based upon factors such as metastasis location, pain, fatigue, confidence and current exercise levels. Behavioural change strategies and education on exercise benefits, safety and lifestyle are also tailored through the website. The primary outcome will be intervention feasibility (safety, usability, acceptability, and adherence). Secondary exploratory outcomes include changes in physical activity, quality of life, sleep, and physical function. Outcomes will be measured at baseline and week 9. Discussion The study aims to determine the potential feasibility of an online remotely monitored exercise intervention developed for individuals with metastatic prostate cancer. If feasible, this pilot intervention will inform the design and implementation of further distance-based interventions. Trial registration ANZCTR, ACTRN12614001268639. Registered 10 December 2018, https://anzctr.org.au/ACTRN12618001979246.aspx

scholarly journals Efficacy of Doll thErapy compared with standard treatment in the control of behavioral and psychologic Symptoms and CaRegIver Burden in dEmentia: DESCRIBE a randomized, controlled study

2021 ◽  
pp. 79
Author(s):  
Keyword(s):  
Caregiver Burden ◽  
Psychotropic Drugs ◽  
Standard Treatment ◽  
Nursing Home Residents ◽  
Controlled Study ◽  
First Line ◽  
Clinical Scales ◽  
Geriatric Unit ◽  
Professional Caregiver ◽  
Collateral Effects

Behavioral and psychologic symptoms of dementia (BPSD) are frequent and represent a burden for patients and caregivers; in particular, the presence of agitation and aggression (A/A) has an important impact on patients’ quality of life. As psychotropic drugs can induce severe collateral effects, the use of a first line non-pharmacologic approach is highly recommended. Here we evaluate the effect of doll therapy (DT) on A/A in geriatric patients with moderate to severe dementia hospitalized in an acute geriatric unit. We enrolled fifty-two acute in-patients with dementia and A/A. Subjects were randomized to DT (26) or standard treatment (ST, 26), we measured agitation and caregiver burden with standard clinical scales at baseline and during treatment. In order to evaluate the effect of DT withdrawal, we carried out a telephonic follow-up interview after 1 and 4 weeks from hospital discharge. DT is more effective than ST in the control of agitation, but not in reducing the professional caregiver burden. The use of pro re nata psychotropic drugs was reduced in patients treated with DT. After DT withdrawal, A/A progressively increased. In conclusion we show that DT may be more effective than ST in the control of A/A in acute geriatric in-patients affected by dementia. Our results suggest that, in patients affected by severe to moderate forms of dementia with A/A, DT may be used as a first line treatment, not only in nursing home residents, but also in acute care geriatric in-patients.

scholarly journals Enhancing sleep quality for nursing home residents with dementia: a pragmatic randomized controlled trial of an evidence-based frontline huddling program

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
A. Lynn Snow ◽  
Julia Loup ◽  
Robert O. Morgan ◽  
Kathy Richards ◽  
Patricia A. Parmelee ◽  
...  
Keyword(s):  
Nursing Home ◽  
Nursing Homes ◽  
Study Protocol ◽  
Medication Use ◽  
Nursing Home Residents ◽  
Evidence Based ◽  
Phase 2 ◽  
Randomized Controlled ◽  
Link Type ◽  
The Impact

Abstract Background Disturbed sleep places older adults at higher risk for frailty, morbidity, and even mortality. Yet, nursing home routines frequently disturb residents’ sleep through use of noise, light, or efforts to reduce incontinence. Nursing home residents with Alzheimer’s disease and or related dementias—almost two-thirds of long-stay nursing home residents—are likely to be particularly affected by sleep disturbance. Addressing these issues, this study protocol implements an evidence-based intervention to improve sleep: a nursing home frontline staff huddling program known as LOCK. The LOCK program is derived from evidence supporting strengths-based learning, systematic observation, relationship-based teamwork, and efficiency. Methods This study protocol outlines a NIH Stage III, real-world hybrid efficacy-effectiveness pragmatic trial of the LOCK sleep intervention. Over two phases, in a total of 27 non-VA nursing homes from 3 corporations, the study will (1) refine the LOCK program to focus on sleep for residents with dementia, (2) test the impact of the LOCK sleep intervention for nursing home residents with dementia, and (3) evaluate the intervention’s sustainability. Phase 1 (1 year; n = 3 nursing homes; 1 per corporation) will refine the intervention and train-the-trainer protocol and pilot-tests all study methods. Phase 2 (4 years; n = 24 nursing homes; 8 per corporation) will use the refined intervention to conduct a wedge-design randomized, controlled, clinical trial. Phase 2 results will measure the LOCK sleep intervention’s impact on sleep (primary outcome) and on psychotropic medication use, pain and analgesic medication use, and activities of daily living decline (secondary outcomes). Findings will point to inter-facility variation in the program’s implementation and sustainability. Discussion This is the first study to our knowledge that applies a dementia sleep intervention to systematically address known barriers to nursing home quality improvement efforts. This innovative study has future potential to address clinical issues beyond sleep (safety, infection control) and expand to other settings (assisted living, inpatient mental health). The study’s strong team, careful consideration of design challenges, and resulting rigorous, pragmatic approach will ensure success of this promising intervention for nursing home residents with dementia. Trial registration NCT04533815, ClinicalTrials.gov, August 20, 2020. 

scholarly journals Effect of functional electrical stimulation versus TheraTogs on gait and balance in children with hemiplegic cerebral palsy: a randomized controlled trial

2021 ◽  
Vol 26 (1) ◽  
Author(s):  
Shamekh Mohamed El-Shamy ◽  
Ehab Mohamed Abd El Kafy
Keyword(s):  
Cerebral Palsy ◽  
Electrical Stimulation ◽  
Functional Electrical Stimulation ◽  
Postural Stability ◽  
Controlled Trial ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Link Type ◽  
Hemiplegic Cerebral Palsy ◽  
Gait Parameters

Abstract Background Children with cerebral palsy exhibit postural restrictions and gait problems as a result of both primary and secondary brain damage impairments. One of the main goals of cerebral palsy rehabilitation is to improve gait and balance. As a result, the purpose of this study was to compare the effects of FES and TheraTogs on gait and balance in children with hemiplegic CP. A randomized controlled study was conducted on 30 children with hemiplegic CP (18 boys and 12 girls) between the ages of 8 and 12 years. The children were divided into two equal groups. In addition to the traditional physical treatment program, the FES group received functional electrical stimulation (pulse width 300 μs, frequency 33 Hz, 2 h/day, 3 days/week, 3 months). The TheraTogs group, on the other hand, received the TheraTogs strapping system as well as the same traditional program for the same time period. The 3-D motion analysis and the Biodex balance system were used to analyze gait parameters and postural stability at baseline and 3 months after the intervention. Results When comparing the mean values of the gait parameters and postural stability indices of children in both groups before and after treatment, a significant improvement was reported. Furthermore, the FES group showed a greater improvement in all of the measured outcomes (P < 0.001). Conclusion Functional electrical stimulation improves gait pattern and postural stability in children with hemiplegic cerebral palsy significantly more than TheraTogs strapping systems. Clinical trial registration This study was registered in the ClinicalTrial.gov PRS (NCT05020834).

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