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Intensive Balance Training for Adults With Incomplete Spinal Cord Injuries: Protocol for an Assessor-Blinded Randomized Clinical Trial.

ABSTRACT: BACKGROUND:Impaired reactive balance control can lead to increased falls in people with neurological impairments. Perturbation-based balance training (PBT), which involves repetitive exposure to destabilizing external perturbations, improves the ability to take reactive steps in older adults and individuals who have had a stroke. OBJECTIVE:The objective is to investigate whether PBT or conventional intensive balance training (CIBT) results in greater improvements in reactive stepping ability in individuals with chronic incomplete spinal cord injury (iSCI). DESIGN:The design consists of an assessor-blind randomized clinical trial comparing the efficacy of 2 balance training programs (PBT and CIBT) matched for training duration (thrice weekly for 8 weeks). SETTING:A tertiary spinal cord injury rehabilitation center is used as the setting. PARTICIPANTS:Participants include 24 adults with iSCI classified as a C or D on the American Spinal Association Impairment Scale, who are able to stand independently and exhibit moderate trunk control. INTERVENTION:Both PBT and CIBT involve 24 sessions, each 1 hour long, of individualized static and dynamic balance tasks. However, PBT includes external, unexpected balance perturbations provided manually by the trainer at a frequency of roughly 1 per training minute. MEASUREMENTS:The primary outcome is the ability to recover balance using a single step during the Lean-and-Release test, a novel method of assessing reactive balance. Secondary outcomes include a number of clinical balance and gait assessments, and the number of falls experienced in a 6-month follow-up period. Semi-structured interviews are conducted 3 months after training completion to gain insight into the participants' perceptions of the impact of the interventions. LIMITATIONS:A control group receiving "standard care" for balance training is not included. CONCLUSIONS:This trial will provide physical therapists with insight into the efficacy of 2 forms of balance training for individuals with iSCI.

SUBMITTER: Unger J

PROVIDER: S-EPMC6438350 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Intensive Balance Training for Adults With Incomplete Spinal Cord Injuries: Protocol for an Assessor-Blinded Randomized Clinical Trial.

Unger Janelle J Chan Katherine K Scovil Carol Y CY Craven B Catharine BC Mansfield Avril A Masani Kei K Musselman Kristin E KE

Physical therapy 20190401 4

<h4>Background</h4>Impaired reactive balance control can lead to increased falls in people with neurological impairments. Perturbation-based balance training (PBT), which involves repetitive exposure to destabilizing external perturbations, improves the ability to take reactive steps in older adults and individuals who have had a stroke.<h4>Objective</h4>The objective is to investigate whether PBT or conventional intensive balance training (CIBT) results in greater improvements in reactive stepp ...[more]

PMID: 30576475

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Project description:Introduction: Impaired balance leads to falls in individuals with motor incomplete spinal cord injury or disease (iSCI/D). Reactive stepping is a strategy used to prevent falls and Perturbation-based Balance Training (PBT) can improve this ability. Objective: The objective of this study was to determine if PBT results in greater improvements in reactive stepping ability than frequency-matched Conventional Intensive Balance Training (CIBT) in adults with iSCI/D. Design: Randomized clinical trial. Setting: Tertiary SCI/D rehabilitation center. Participants: Twenty-one adults with chronic (>1 year) iSCI/D were randomized. Due to one drop out 20 participants completed the study. Methods: Participants were randomly allocated to complete either PBT or CIBT three times per week for 8 weeks. Both programs included challenging static and dynamic balance tasks, but the PBT group also experienced manual external balance perturbations. Main Outcome Measures: Assessments of reactive stepping ability using the Lean-and-Release test were completed at baseline, and after 4 and 8 weeks of training, and 3 and 6 months after training completion. A blinded assessor evaluated secondary outcomes. Results: Twenty-five participants were screened and 21 consented; one withdrew. Ten PBT and 10 CIBT participants were included in analyses. Across all participants there were improvements in reactive stepping ability (p = 0.049), with retention of improvements at follow up assessments. There were no differences in reactive stepping ability between groups [median (interquartile range): PBT 0.08 (0.68); CIBT 0.00 (0.22)]. One participant in the PBT group experienced a non-injurious fall during training. Conclusions: Balance training is beneficial for individuals with iSCI/D, but the addition of manual perturbations (i.e., PBT) did not prove advantageous for performance on a measure of reactive stepping ability. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT02960178.

Project description:IntroductionPeople with spinal cord injury receive physical rehabilitation to promote neurological recovery. Physical rehabilitation commences as soon as possible when a person is medically stable. One key component of physical rehabilitation is motor training. There is initial evidence to suggest that motor training can enhance neurological recovery if it is provided soon after injury and in a high dosage. The Early and Intensive Motor Training Trial is a pragmatic randomised controlled trial to determine whether 10 weeks of intensive motor training enhances neurological recovery for people with spinal cord injury. This pragmatic randomised controlled trial will recruit 220 participants from 15 spinal injury units in Australia, Scotland, Italy, Norway, England, Belgium and the Netherlands. This protocol paper describes the process evaluation that will run alongside the Early and Intensive Motor Training Trial. This process evaluation will help to explain the trial results and explore the potential facilitators and barriers to the possible future rollout of the trial intervention.Methods and analysisThe UK Medical Research Council process evaluation framework and the Implementation Research Logic Model will be used to explain the trial outcomes and inform future implementation. Key components of the context, implementation and mechanism of impact, as well as the essential elements of the intervention and outcomes, will be identified and analysed. Qualitative and quantitative data will be collected and triangulated with the results of the Early and Intensive Motor Training Trial to strengthen the findings of this process evaluation.Ethics and disseminationEthical approval for the Early and Intensive Motor Training Trial and process evaluation has been obtained from the Human Research Ethics Committee at the Northern Sydney Local Health District (New South Wales) in Australia (project identifier: 2020/ETH02540). All participants are required to provide written consent after being informed about the trial and the process evaluation. The results of this process evaluation will be published in peer-reviewed journals.Trial registration numberAustralian New Zealand Clinical Trial Registry (ACTRN12621000091808); Universal Trial Number (U1111-1264-1689).

Project description:Objective: To evaluate the immediate and long-term effects of 12 weeks of Tai Chi training on dynamic balance and disease severity among individuals with cerebellar ataxia (CA). Design: An assessor-blinded, two-arm, parallel-group randomized-controlled trial was conducted among 24 participants with CA. Participants were randomized to receive either Tai Chi intervention (n = 12) or usual care (n = 12). Dynamic balance was assessed using the Berg Balance Scale (BBS), Scale for the Assessment and Rating of Ataxia (SARA) balance sub-component of the SARA (SARAbal), Sensory Organization Test, and Limits of Stability test. Disease severity was assessed using the SARA and health-related quality of life using the EuroQol visual analog scale. Assessments were completed at baseline (week 0: T1), postintervention (week 12: T2), and at the end of the 24-week (week 36: T3) follow-up period. Interventions: The 8-form Tai Chi exercise was delivered in 60-min sessions, three times a week for 12 weeks. Participants were asked to complete an unsupervised home Tai Chi exercise program over the next 24 weeks. Participants in the usual care control group completed all study measures but did not receive any intervention. Results: Compared with the usual care control group, after 12 weeks of Tai Chi training, the experimental group demonstrated beneficial effects for dynamic balance assessed using the BBS (mean difference [MD]: 4, 95% confidence interval [CI]: -1.06 to 8.71) and the SARAbal (MD: -1.33, 95% CI: -2.66 to 2.33). The effect size ranged from small to large. The benefits gained were not sustained after 24 weeks during the follow-up assessment. Tai Chi did not benefit disease severity and health-related quality of life in this population. Conclusion: Some evidence supports the immediate beneficial effects of 12 weeks of Tai Chi training on the dynamic balance among individuals with CA. Australia New Zealand Clinical Trials Registry (ACTRN12617000327381).

Project description:Key factors positively influencing rehabilitation and functional recovery after spinal cord injury (SCI) include training variety, intensive movement repetition, and motivating training tasks. Systems supporting these aspects may provide profound gains in rehabilitation, independent of the subject's treatment location. In the present study, we test the hypotheses that virtual reality (VR)-augmented training at home (i.e., unsupervised) is feasible with subjects with an incomplete SCI (iSCI) and that it improves motor functions such as lower limb muscle strength, balance, and functional mobility. In the study, 12 chronic iSCI subjects used a home-based, mobile version of a lower limb VR training system. The system included motivating training scenarios and combined action observation and execution. Virtual representations of the legs and feet were controlled via movement sensors. The subjects performed home-based training over 4?weeks, with 16-20 sessions of 30-45?min each. The outcome measures assessed were the Lower Extremity Motor Score (LEMS), Berg Balance Scale (BBS), Timed Up and Go (TUG), Spinal Cord Independence Measure mobility, Walking Index for Spinal Cord Injury II, and 10?m and 6?min walking tests. Two pre-treatment assessment time points were chosen for outcome stability: 4?weeks before treatment and immediately before treatment. At post-assessment (i.e., immediately after treatment), high motivation and positive changes were reported by the subjects (adapted Patients' Global Impression of Change). Significant improvements were shown in lower limb muscle strength (LEMS, P?=?0.008), balance (BBS, P?=?0.008), and functional mobility (TUG, P?=?0.007). At follow-up assessment (i.e., 2-3?months after treatment), functional mobility (TUG) remained significantly improved (P?=?0.005) in contrast to the other outcome measures. In summary, unsupervised exercises at home with the VR training system led to beneficial functional training effects in subjects with chronic iSCI, suggesting that it may be useful as a neurorehabilitation tool. Trial registration:Canton of Zurich ethics committee (EK-24/2009, PB_2016-00545), ClinicalTrials.gov: NCT02149186. Registered 24 April 2014.

Dataset Information

Intensive Balance Training for Adults With Incomplete Spinal Cord Injuries: Protocol for an Assessor-Blinded Randomized Clinical Trial.

Publications

Intensive Balance Training for Adults With Incomplete Spinal Cord Injuries: Protocol for an Assessor-Blinded Randomized Clinical Trial.

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