scholarly journals A randomized controlled feasibility trial exploring partnered ballroom dancing for people with Parkinson’s disease

2017 ◽  
Vol 31 (10) ◽  
pp. 1340-1350 ◽  
Author(s):  
D Kunkel ◽  
C Fitton ◽  
L Roberts ◽  
RM Pickering ◽  
HC Roberts ◽  
...  
Keyword(s):  
Qualitative Interviews ◽  
Phase Iii ◽  
Feasibility Trial ◽  
Control Group ◽  
Phase Iii Trial ◽  
Dance Class ◽  
Organizational Challenges ◽  
Randomized Controlled ◽  
Dance Teachers ◽  
Experimental Group

Objective: To determine the feasibility of a Dance Centre delivering a programme of mixed dances to people with Parkinson’s and identify suitable outcomes for a future definitive trial. Design: A two-group randomized controlled feasibility trial. Methods: People with Parkinson’s were randomized to a control or experimental group (ratio 15:35), alongside usual care. In addition, participants in the experimental group danced with a partner for one hour, twice-a-week for 10 weeks; professional dance teachers led the classes and field-notes were kept. Control-group participants were given dance class vouchers at the end of the study. Blinded assessments of balance, mobility and function were completed in the home. Qualitative interviews were conducted with a subsample to explore the acceptability of dance. Results: A total of 51 people with Parkinson’s (25 male) with Hoehn and Yahr scores of 1–3 and mean age of 71 years (range 49–85 years), were recruited to the study. Dance partners were of similar age (mean 68, range 56–91 years). Feasibility findings focused on recruitment (target achieved); retention (five people dropped out of dancing); outcome measures (three measures were considered feasible, changes were recommended). Proposed sample size for a Phase III trial, based on the 6-minute walk test at six months was 220. Participants described dance as extremely enjoyable and the instructors were skilled in instilling confidence and motivation. The main organizational challenges for a future trial were transport and identifying suitable dance partners. Conclusion: We have demonstrated the feasibility of conducting the study through a Dance Centre and recommend a Phase III trial.

scholarly journals Use of the Chatbot “Vivibot” to Deliver Positive Psychology Skills and Promote Well-Being Among Young People After Cancer Treatment: Randomized Controlled Feasibility Trial

10.2196/15018 ◽  
2019 ◽  
Vol 7 (10) ◽  
pp. e15018 ◽  
Author(s):  
Stephanie Greer ◽  
Danielle Ramo ◽  
Yin-Juei Chang ◽  
Michael Fu ◽  
Judith Moskowitz ◽  
...  
Keyword(s):  
Young Adults ◽  
Positive Psychology ◽  
Cancer Treatment ◽  
Negative Emotion ◽  
Well Being ◽  
Feasibility Trial ◽  
Control Group ◽  
Depression Symptoms ◽  
Randomized Controlled ◽  
Experimental Group

Background Positive psychology interventions show promise for reducing psychosocial distress associated with health adversity and have the potential to be widely disseminated to young adults through technology. Objective This pilot randomized controlled trial examined the feasibility of delivering positive psychology skills via the Vivibot chatbot and its effects on key psychosocial well-being outcomes in young adults treated for cancer. Methods Young adults (age 18-29 years) were recruited within 5 years of completing active cancer treatment by using the Vivibot chatbot on Facebook messenger. Participants were randomized to either immediate access to Vivibot content (experimental group) or access to only daily emotion ratings and access to full chatbot content after 4 weeks (control). Created using a human-centered design process with young adults treated for cancer, Vivibot content includes 4 weeks of positive psychology skills, daily emotion ratings, video, and other material produced by survivors, and periodic feedback check-ins. All participants were assessed for psychosocial well-being via online surveys at baseline and weeks 2, 4, and 8. Analyses examined chatbot engagement and open-ended feedback on likability and perceived helpfulness and compared experimental and control groups with regard to anxiety and depression symptoms and positive and negative emotion changes between baseline and 4 weeks. To verify the main effects, follow-up analyses compared changes in the main outcomes between 4 and 8 weeks in the control group once participants had access to all chatbot content. Results Data from 45 young adults (36 women; mean age: 25 [SD 2.9]; experimental group: n=25; control group: n=20) were analyzed. Participants in the experimental group spent an average of 74 minutes across an average of 12 active sessions chatting with Vivibot and rated their experience as helpful (mean 2.0/3, SD 0.72) and would recommend it to a friend (mean 6.9/10; SD 2.6). Open-ended feedback noted its nonjudgmental nature as a particular benefit of the chatbot. After 4 weeks, participants in the experimental group reported an average reduction in anxiety of 2.58 standardized t-score units, while the control group reported an increase in anxiety of 0.7 units. A mixed-effects models revealed a trend-level (P=.09) interaction between group and time, with an effect size of 0.41. Those in the experimental group also experienced greater reductions in anxiety when they engaged in more sessions (z=–1.9, P=.06). There were no significant (or trend level) effects by group on changes in depression, positive emotion, or negative emotion. Conclusions The chatbot format provides a useful and acceptable way of delivering positive psychology skills to young adults who have undergone cancer treatment and supports anxiety reduction. Further analysis with a larger sample size is required to confirm this pattern.

scholarly journals Improving Transplant Opportunities for Patients who are Sensitized (ITOPS): Protocol for a Feasibility, Randomized, Controlled, Phase III Clinical Trial

2020 ◽  
Author(s):  
Sian Griffin ◽  
Tracey Rees ◽  
Samaher Sweity ◽  
Helen Williams ◽  
Laura Pankhurst ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Proteasome Inhibition ◽  
Phase Iii ◽  
Feasibility Trial ◽  
Control Group ◽  
Specific Antibodies ◽  
Randomized Controlled ◽  
Absolute Reduction

Abstract • Background: Kidney transplantation offers a better quality of life and a clear survival advantage compared to long-term dialysis. However, rates of transplantation are low for highly sensitized patients (HSP) who have a broad specificity of human leucocyte antigen (HLA) specific antibodies. This is because the presence of pre-formed HLA Donor Specific Antibodies can result in hyperacute rejection and is an immunological veto to transplantation. The proportion of eligible donors therefore decreases with increasing sensitization, resulting in increased waiting time prior to transplantation. This study aims to assess the efficacy of a combination of B cell depletion and proteasome inhibition, together with antibody removal and steroids, to reduce HLA antibodies in HSP, predicted to improve rates of transplantation, and to determine the feasibility of conducting a future definitive trial. • Methods: ITOPS is a multi-center, randomized parallel, non-blinded, controlled phase III feasibility trial. The participants will be allocated in a 1:1 ratio to either the trial intervention (rituximab followed by 1-2 cycles of plasmapheresis, bortezomib and dexamethasone) or control group (no intervention). • Discussion: The primary outcome is the proportion of patients achieving an absolute reduction in sensitization (calculated reaction frequency, cRF) of at least 10% at 12 weeks following their last intervention, compared to the control group. Secondary outcomes include recruitment and transplantation rates, durability of change and absolute percentage change in cRF, and acceptability of the intervention. We will proceed to development of a larger trial if at least 50% of the participants in the intervention arm achieve an absolute reduction in cRF of a minimum of 10% at 12 weeks following their last intervention. If the proportion is <50% in the intervention arm but 50% is included within the 95% confidence interval, then consideration to proceed to a larger randomized trial will be given alongside other aspects of feasibility.• Trial Registration: International Standard Randomized Controlled Trial Number ISRCTN66441193 https://doi.org/10.1186/ISRCTN66441193

scholarly journals Use of the Chatbot “Vivibot” to Deliver Positive Psychology Skills and Promote Well-Being Among Young People After Cancer Treatment: Randomized Controlled Feasibility Trial (Preprint)

2019 ◽  
Author(s):  
Stephanie Greer ◽  
Danielle Ramo ◽  
Yin-Juei Chang ◽  
Michael Fu ◽  
Judith Moskowitz ◽  
...  
Keyword(s):  
Young Adults ◽  
Positive Psychology ◽  
Cancer Treatment ◽  
Negative Emotion ◽  
Well Being ◽  
Feasibility Trial ◽  
Control Group ◽  
Depression Symptoms ◽  
Randomized Controlled ◽  
Experimental Group

BACKGROUND Positive psychology interventions show promise for reducing psychosocial distress associated with health adversity and have the potential to be widely disseminated to young adults through technology. OBJECTIVE This pilot randomized controlled trial examined the feasibility of delivering positive psychology skills via the <italic>Vivibot</italic> chatbot and its effects on key psychosocial well-being outcomes in young adults treated for cancer. METHODS Young adults (age 18-29 years) were recruited within 5 years of completing active cancer treatment by using the <italic>Vivibot</italic> chatbot on Facebook messenger. Participants were randomized to either immediate access to <italic>Vivibot</italic> content (experimental group) or access to only daily emotion ratings and access to full chatbot content after 4 weeks (control). Created using a human-centered design process with young adults treated for cancer, <italic>Vivibot</italic> content includes 4 weeks of positive psychology skills, daily emotion ratings, video, and other material produced by survivors, and periodic feedback check-ins. All participants were assessed for psychosocial well-being via online surveys at baseline and weeks 2, 4, and 8. Analyses examined chatbot engagement and open-ended feedback on likability and perceived helpfulness and compared experimental and control groups with regard to anxiety and depression symptoms and positive and negative emotion changes between baseline and 4 weeks. To verify the main effects, follow-up analyses compared changes in the main outcomes between 4 and 8 weeks in the control group once participants had access to all chatbot content. RESULTS Data from 45 young adults (36 women; mean age: 25 [SD 2.9]; experimental group: n=25; control group: n=20) were analyzed. Participants in the experimental group spent an average of 74 minutes across an average of 12 active sessions chatting with <italic>Vivibot</italic> and rated their experience as helpful (mean 2.0/3, SD 0.72) and would recommend it to a friend (mean 6.9/10; SD 2.6). Open-ended feedback noted its nonjudgmental nature as a particular benefit of the chatbot. After 4 weeks, participants in the experimental group reported an average reduction in anxiety of 2.58 standardized t-score units, while the control group reported an increase in anxiety of 0.7 units. A mixed-effects models revealed a trend-level (<italic>P</italic>=.09) interaction between group and time, with an effect size of 0.41. Those in the experimental group also experienced greater reductions in anxiety when they engaged in more sessions (z=–1.9, <italic>P</italic>=.06). There were no significant (or trend level) effects by group on changes in depression, positive emotion, or negative emotion. CONCLUSIONS The chatbot format provides a useful and acceptable way of delivering positive psychology skills to young adults who have undergone cancer treatment and supports anxiety reduction. Further analysis with a larger sample size is required to confirm this pattern.

A multicenter, randomized, phase III trial of short-term radiotherapy plus chemotherapy versus long-term chemoradiotherapy in locally advanced rectal cancer (STELLAR): The final reports.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 3510-3510
Author(s):  
Jing Jin ◽  
Yuan Tang ◽  
Chen Hu ◽  
Yong Cai ◽  
Yuan Zhu ◽  
...  
Keyword(s):  
Locally Advanced ◽  
Advanced Rectal Cancer ◽  
Locally Advanced Rectal Cancer ◽  
Phase Iii ◽  
Control Group ◽  
Preoperative Treatment ◽  
Phase Iii Trial ◽  
And Control ◽  
Experimental Group

3510 Background: It’s presented the results of a phase III trial of short-term radiotherapy (SCRT) combined with chemotherapy versus long-term chemoradiotherapy (LCRT) in patients with locally advanced rectal cancer (LARC). Methods: Patients with distal or middle third, T3-T4 and/or N+ rectal adenocarcinomas diagnosed by MRI, were randomly assigned to experimental group or control group. In experimental group, patients received SCRT (25 Gy / 5 fractions / 5 days), followed by four courses of CAPOX. In control group, patients received LCRT (50 Gy / 25 fractions / 35 days with concurrent capecitabine). Surgery was recommended in both groups and performed 6-8 weeks after preoperative treatment. Two or six courses of CAPOX was prescribed as the postoperative chemotherapy in experimental group and control group, respectively. This trial was a multicenter, open-label, randomized, noninferior, phase III study, and all the patients were from 16 hospitals of China. The primary endpoint for this study was 3-year disease-free survival (DFS). Results: From Aug 30, 2015 to Aug 27, 2018, 599 patients were enrolled and entered random. Finally, 591 intention-to-treat (ITT) populations were included in the analysis, 298 patients assigned to SCRT followed by chemotherapy and 293 to CRT. For the experimental group and control group, cT3 and cT4 accounted for 82.3% vs. 84.6% and 15.4% vs. 12.3%, respectively, and approximately 85% were mrN positive (85.6% vs. 84.0%). As a whole, the completion and full-dose completion rates of preoperative treatment were 82.6% vs. 95.2% (p＜0.001) and 74.8% vs 93.2% (p＜0.001) in the experimental and control groups, respectively. Among the 465 patients who received surgery, 16.6% and 11.8% of them achieved pCR (p=0.134), respectively. Accounting for cCR after preoperative treatment, the total rate of pCR+cCR in experimental group was 22.5% and significantly higher than control group (12.6%, p=0.001). With median follow-up 35.0 months, the HR between experimental and control of DFS was 0.883, with 1-sided noninferiority p-value <0.001, so the noninferiority hypothesis was confirmed. The probability of DFS and OS at 3 years was 64.5% and 86.5% in the experimental group compared with 62.3% and 75.1% in control group. It’s observed the OS rate of the experimental group was significantly higher than that of the control group (p=0.036) and no significant difference in metastasis-free survival or loco-regional recurrence was observed. Conclusions: For LARC with high risk factors, SCRT combined with sequential chemotherapy was noninferior to CRT and could be used as an alternative to LCRT. Meanwhile, SCRT combined with chemotherapy presented a higher cCR+pCR and 3-year overall survival rates as compared with CRT. However, the long term results need to be further followed up. (ClinicalTrails No.: NCT02533271 ). Clinical trial information: NCT00833131.

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 Efficacy of axial TheraTogs on gait pattern in children with dyskinetic 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 ◽  
Physical Therapy ◽  
Muscle Tone ◽  
Controlled Trial ◽  
Gait Pattern ◽  
Controlled Study ◽  
Control Group ◽  
Randomized Controlled ◽  
Gait Parameters ◽  
Experimental Group

Abstract Background TheraTogs promotes proprioceptive sense of a child with cerebral palsy and improves abnormal muscle tone, posture alignment, balance, and gait. Therefore, the aim of this study was to investigate the efficacy of TheraTogs orthotic undergarment on gait pattern in children with dyskinetic cerebral palsy. Thirty children with dyskinetic cerebral palsy were selected for this randomized controlled study. They were randomly assigned to (1) an experimental group that received TheraTogs orthotic undergarment (12 h/day, 3 days/week) plus traditional physical therapy for 3 successive months and (2) a control group that received only traditional physical therapy program for the same time period. Gait parameters were measured at baseline and after 3 months of intervention using Pro-Reflex motion analysis. Results Children in both groups showed significant improvements in the gait parameters (P < 0.05), with significantly greater improvements in the experimental group than in the control group. Conclusions The use of TheraTogs may have a positive effect to improve gait pattern in children with dyskinetic cerebral palsy. Trial registration This trial was registered in the ClinicalTrial.gov PRS (NCT03037697).

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.

scholarly journals The effects of transcutaneous electrical nerve stimulation during the first stage of labor: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Anne Njogu ◽  
Si Qin ◽  
Yujie Chen ◽  
Lizhen Hu ◽  
Yang Luo
Keyword(s):  
Transcutaneous Electrical Nerve Stimulation ◽  
Controlled Trial ◽  
Labor Pain ◽  
Control Group ◽  
Electrical Nerve Stimulation ◽  
Randomized Controlled ◽  
Active Labor ◽  
Vas Scores ◽  
Experimental Group ◽  
First Stage Of Labor

Abstract Background Labor pain during childbirth can have devastating effects on the progress of labor, mother, and fetus. Consequently, the management of labor pain is crucial for the well-being of the mother and fetus. Transcutaneous electrical nerve stimulation (TENS) is a non -pharmacological analgesic technique. It uses a low-voltage electrical current to activate descending inhibitory systems in the central nervous system to relieve pain. This study aimed to determine the effects of TENS therapy in the first stage of labor. Methods In this single-blind randomized controlled trial, we screened low-risk pregnant women who anticipated spontaneous vaginal delivery. Women were assigned (1:1) to either the experimental group (received TENS therapy in the first stage of labor) or the control group (received routine obstetric care). The women, midwives, and researchers working in the gynecology and obstetric department were aware of the treatment group, but statisticians analysis the data were blinded. The primary outcome was labor pain intensity, assessed by visual analog scale (VAS) immediately after the randomization, at 30, 60, and 120 min after TENS therapy, and 2–24 h post-delivery. We used SPSS 21.0 software in data analysis. An independent sample t-test compared the mean VAS scores and labor duration between groups. A Chi-square test was employed to compare categorical variables between the groups. A significant level of ≤0.05 was statistically significant. Results A total of 326 pregnant women were eligible: experimental group (n = 161) and control group (n = 165). The experimental group had statistically significantly lower mean VAS scores at a different time (30, 60, and 120 min post-intervention and 2–24 h post-delivery) than the control group (p < 0.001). The experimental group demonstrated a statistically significant shorter duration of the active labor phase than the control group (p < 0.001). Conclusion This study indicates that TENS can be used as a non-pharmacological therapy to reduce pain and shorten the active labor phase. Trial registration ISRCTN registry, ISRCTN23857995. Registered on 11/12/2020, ‘retrospectively registered.

Sign in / Sign up

Export Citation Format

Share Document