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High Level Mobility Training in Ambulatory Patients with Acquired Non-Progressive Central Neurological Injury: a Feasibility Study

Gallo, Estelle; Yao, Lanqiu; Tarpey, Thaddeus; Cepeda, Jaime; Connors, Katie Ann; Kedzierska, Iwona; Rao, Smita
The purpose of this study was to test the feasibility and safety of High-Level Mobility (HLM) training on adults with Acquired Brain Injury (ABI). Our hypotheses were that HLM training would be feasible and safe. This study was a pilot randomized control trial with a Simple Skill Group (SSG) and a Complex Skill Group (CSG). Both groups received 12 sessions over 8 weeks and completed 4 testing sessions over 16 weeks. The SSG focused on locomotion, while CSG focused on the acquisition of running. Feasibility was assessed in terms of process, resources, management, and scientific metrics, including safety. Among the 41 participants meeting inclusion criteria, 28 consented (CSG, n = 13, SSG, n = 15), 20 completed the assigned protocol and 8 withdrew (CSG n = 4, SSG n = 4). Adherence rate to assigned protocol was 100%. There were two Adverse Events (AEs), 1 over 142 SSG sessions and 1 over 120 CSG sessions. The AE Odd Ratio (OR) (CSG:SSG) was 1.18 (95% CI: 0.07, 19.15). The data support our hypotheses that HLM training is feasible and safe on ambulatory adults with ABI.
PMID: 35138211
ISSN: 1362-301x
CID: 5156422

Assessing upper limb function in multiple sclerosis using an engineered glove

Carmisciano, L; Signori, A; Pardini, M; Novi, G; Lapucci, C; Nesi, L; Gallo, E; Laroni, A; Cellerino, M; Meli, R; Sbragia, E; Filippi, L; Uccelli, A; Inglese, M; Sormani, M P
BACKGROUND AND PURPOSE/OBJECTIVE:The importance of upper limb function in multiple sclerosis (MS) is increasingly recognized, especially for the evaluation of patients with progressive MS with reduced mobility. Two sensor-engineered gloves, able to measure quantitatively the timing of finger opposition movements, were previously used to assess upper limb disability in MS. The aims of the present study were: (1) to confirm the association between glove-derived variables and standard measures of MS disability in a larger cohort; (2) to assess the correlation with quantitative magnetic resonance imaging (MRI) and quality of life (QoL) measures; and (3) to determine if the glove-derived variables offer advantages over the standard measure for assessing upper limb function in MS, namely, the Nine-Hole Peg Test (9HPT). METHODS:Sixty-five patients with MS, stable on disease-modifying treatment, were evaluated at baseline using the glove, and through clinical examination (Expanded Disability Status Scale, Symbol Digit Modalities Test, Timed 25-Foot Walk Test and 9HPT), MRI evaluation and QoL questionnaires. Correlations between the glove-derived variables and clinical, MRI and QoL variables were assessed using Spearman's rank correlation coefficient analysis. RESULTS:Glove-derived variables significantly differed between patients with relapsing-remitting and those with progressive MS, with similar or slightly higher correlations of the 9HPT with clinical variables. We found greater correlations of the QoL physical component with glove-derived variables than with the 9HPT, and a significant correlation of its mental component with the glove-derived variables but not with the 9HPT. CONCLUSION/CONCLUSIONS:The study results, confirming previous findings and showing advantages over the 9HPT, encourage the investigation of sensitivity to change in glove-derived variables in a longitudinal setting.
PMID: 32805743
ISSN: 1468-1331
CID: 4673372

Determining Whether a Dosage-Specific and Individualized Home Exercise Program With Consults Reduces Fall Risk and Falls in Community-Dwelling Older Adults With Difficulty Walking: A Randomized Control Trial

Gallo, Estelle; Stelmach, Maria; Frigeri, Fernanda; Ahn, Dong-Hyun
BACKGROUND AND PURPOSE: The development and implementation of effective interventions to prevent falls in older adults is a public health priority. The purpose of this study was to compare the efficacy of a new practice model, incorporating Shubert's evidence-based fall prevention recommendations, with the usual ambulatory physical therapy (PT) at Rusk Rehabilitation, to decrease fall risk among older adults living in the community. The hypotheses were (1) the proposed program would decrease participants' fall risk, (2) it would be more effective than our usual PT, and (3) the addition of 4 consults after discharge would improve compliance with a home exercise program. METHODS: This was a randomized controlled trial. Sixty-nine participants who were independent community dwellers, were 65 years or older, had difficulty walking or complaints of instability, and had 1 or more risk of falls were randomly assigned into a usual care group (UCG, n = 43) or an experimental group (EG, n = 26). Both groups received PT 2 times per week for 30 minutes for 10 to 32 visits. The UCG received the usual PT delivered at Rusk. The EG was instructed in a moderate- to high-intensity home exercise program designed after completing the mini-Balance Evaluation Systems Test to assist with exercise prescription. The EG was educated on performing a recommended dosage of exercise over 6 months using a diary. The EG received 4 additional 30-minute consults every 2 to 4 weeks postdischarge to reinforce compliance. Self-report of number of falls, number of minutes of exercise per week, and performance on outcome measures (Timed Up and Go, 5-times sit-to-stand, Berg Balance Scale, and Activity Balance Confidence Scale) were monitored at evaluation, 2, 4, and 6 months. RESULTS AND DISCUSSION: Thirty-five participants completed the study (UCG n = 22; EG n = 13). Both groups were similar at baseline on outcome measures and number of visits. Random effect model analyses demonstrated that both groups made significant reductions in fall risk over 6 months as identified by performance on outcome measures. However, the EG improved significantly more compared with the UCG over time (P < .05). Linear regression analyses showed that the EG exercised significantly more compared with the UCG at all times (P < .05). The EG exceeded the target of 115 min/wk of exercise (154 minutes, standard deviation [SD] 68.5; 170 minutes, SD 96.8; and 143 minutes, SD 68.5) at 2, 4, and 6 months, respectively. This study demonstrated that the experimental program is effective in decreasing fall risk in community-dwelling older adults and is more effective than our usual care. Moreover, it suggests that the overall experimental protocol may offer an effective strategy to foster adherence to an exercise program without the increasing number of visits. CONCLUSION: This study supports the efficacy of the experimental program in decreasing fall risk and being more effective than our usual care, as well as fostering greater compliance with an exercise regimen. It provides some preliminary evidence to support Shubert's recommendation on exercise prescription for fall prevention.
PMID: 27893567
ISSN: 2152-0895
CID: 2329222

Examining the Effects of a Powered Exoskeleton on Quality of Life and Secondary Impairments in People Living With Spinal Cord Injury

Juszczak, Michael; Gallo, Estelle; Bushnik, Tamara
Background: Secondary impairments associated with spinal cord injury (SCI) limit one's independent functionality and negatively impact quality of life (QoL). Objective: The purpose of this study was to explore changes in secondary health conditions that may result from using a powered exoskeleton as well as their potential impact on QoL. Methods: Forty-five participants presenting with SCI ranging from T3-L2 were included in this study. Outcome measures included self-reported assessments of pain, spasticity, bladder/bowel function, Satisfaction with Life Scale (SWLS), and Modified Ashworth Scale (MAS). Results: Participants reported significantly less spasticity at the conclusion of the study, 0.9 ± 1.7, compared to baseline, 1.6 ± 0.9 [t (44) = 2.83, p < .001]. MAS testing revealed that 26.7% of participants presented with decreased spasticity at the conclusion of the trial. Participants reported less pain at the end of the trial, 0.9 ± 1.6, compared to the start, 1.1 ± 1.7 [t (44) = 1.42, p > .05]. No negative changes in bowel and bladder were reported; positive changes were reported by 20% and 9% of participants with respect to bowel and bladder management. There was no statistically significant change in SWLS sum score from baseline, 20.4 ± 8.0, to conclusion of the study, 21.3 ± 7.6 [t (44) = -1.1, p > .05]. Conclusion: Findings suggest using a powered exoskeleton may decrease spasticity in people living with SCI. Although improvements in secondary impairments did not result in a significant improvement in QoL, it is believed that using a powered exoskeleton in one's community will lead to increased community integration facilitating an improvement in QoL.
PMID: 30459496
ISSN: 1945-5763
CID: 3480602

Pairing TMS and Physical Therapy for Treatment of Gait and Balance Disorders in Parkinson's disease: A Randomized Pilot Trial [Meeting Abstract]

Cucca, A.; Migdadi, H.; Biller, T.; Agarwal, S.; Kumar, P.; Son, A.; Ko, M.; Gallo, E.; Fisher, S.; Di Rocco, A.; Biagioni, M.
ISI:000402672302326
ISSN: 0885-3185
CID: 3195502

Combined differentiating therapy for myelodysplastic syndromes: a phase II study

Ferrero, D; Bruno, B; Pregno, P; Stefani, S; Larizza, E; Ciravegna, G; Luraschi, A; Vietti-Ramus, G; Schinco, P; Bazzan, M; Gallo, E; Pileri, A
An in vitro synergism between different inducers of AML cell differentiation has been previously observed. Therefore, we treated 53 myelodysplastic (MDS) patients with a low dose combination of cis-retinoic acid (cRA, 20-40 mg/day) and 1,25 alpha (OH)2 cholecalciferol [(OH)2D3, 1-1.5 micrograms/day] +/- intermittent 6-thioguanine (30 mg/m2/day). The latter was reserved for patients with bone marrow (BM) blast excess (> or = 5%). The treatment was well tolerated, without major toxicity. Among 25 patients with BM blasts less than 5%, we observed one complete, eight partial and four minor responses (response rate 52%) with a median response duration of 8 months (2 +/- 24). Median survival, which did not correlate with response, is projected at 76 months. Thirty-one patients with BM blast excess (> or = 5%), including three of the previous group who progressed to refractory anemia with excess of blasts (RAEB), were treated with the three-drug protocol. One complete, 12 partial and six minor responses were obtained (response rate 61%) with a median response duration of 6 months (2-29+). A significant difference in survival (P < 0.005) was observed between the 19 responders (median 25 months) and the 12 non-responders (median 9 months). A reduction in the transfusion need was observed in 41% of the transfusion-dependent patients with blast excess and in 53% of those without blast excess. Therefore, combined differentiating therapy seems more effective than previously reported single agent treatments and should be considered for a larger randomized study to assess its actual impact on survival of MDS patients.
PMID: 8960111
ISSN: 0145-2126
CID: 4726852

Generation of anti-tumour activity by OKT3-stimulation in multiple myeloma: in vitro inhibition of autologous haemopoiesis

Attisano, C; Bianchi, A; Montacchini, L; Carlesso, N; Peola, S; Bruno, B; Roux, V; Ferrero, D; Gallo, E; Boccadoro, M
T cells in multiple myeloma (MM) patients are highly susceptible to activation with the anti-CD3 monoclonal antibody (mAb) OKT3. When short-term OKT3 stimulation is carried out on bone marrow mononuclear cells (BMMC), large numbers of CD3+ CD25+ HLA-DR+ cells are rapidly generated and autologous malignant plasma cells are killed. OKT3 may thus be exploited in autologous bone marrow transplantation (ABMT) to purge residual plasma cells and simultaneously activate T cells to induce graft-versus-leukemia-like (GVL-like) activity upon reinfusion. However, the possible impact of ex-vivo short-term OKT3 stimulation on haematological recovery is unknown. The aim of this work was to investigate the effect of OKT3 stimulation in vitro on autologous haemopoietic progenitor cells (HPC) of MM patients. Colony formation by granulocyte-macrophage progenitor cells (granulocyte-macrophage colony-forming units, CFU-GM) was highly suppressed, although supernatants of OKT3-activated T cells contained up to 2,500 pg/ml of granulocyte-macrophage colony-stimulating factor (GM-CSF). T cell depletion completely prevented this suppression. Neutralizing antibodies against TNF-alpha, TNF-beta and IFN-gamma (which are also produced by OKT3-activated MM T cells) did not prevent it, and Transwell cultures showed that cell-to-cell contact was the main mechanism involved. OKT3-activated T cells also suppressed erythroid burst-forming units (BFU-E) and CFU-GM generation from HPC responsible for long-term maintenance of in vitro myelopoiesis. When tested on normal allogeneic BM, MM supernatants of OKT3-stimulated BMMC partially suppressed the generation of day 7 CFU-GM, but had no effect on day 14 CFU-GM. These data indicate that short-term stimulation of BMMC with OKT3 can be used to generate anti-tumour effector T cells for autologous adoptive immunotherapy. It is not a feasable approach for ex-vivo purging and activation procedures in ABMT because of its potent inhibition of autologous haemopoiesis.
PMID: 7993789
ISSN: 0007-1048
CID: 4726832