Dataset Information

A Randomized Controlled Evaluation of the Efficacy of an Ankle-Foot Cast on Walking Recovery Early After Stroke: SWIFT Cast Trial.

ABSTRACT:

Background

Timely provision of an ankle-foot orthosis (AFO) orthotist customized for individuals early after stroke can be problematic.

Objective

To evaluate the efficacy of a therapist-made AFO (SWIFT Cast) for walking recovery.

Methods

This was a randomized controlled, observer-blind trial. Participants (n = 105) were recruited 3 to 42 days poststroke. All received conventional physical therapy (CPT) that included use of "off-the-shelf" and orthotist-made AFOs. People allocated to the experimental group also received a SWIFT Cast for up to 6 weeks. Measures were undertaken before randomization, 6 weeks thereafter (outcome), and at 6 months after stroke (follow-up). The primary measure was walking speed. Clinical efficacy evaluation used analysis of covariance.

Results

Use of a SWIFT Cast during CPT sessions was significantly higher (P < .001) for the SWIFT Cast (55%) than the CPT group (3%). The CPT group used an AFO in 26% of CPT sessions, compared with 11% for the SWIFT Cast group (P = .005). At outcome, walking speed was 0.42 (standard deviation [SD] = 0.37) m/s for the CPT group and 0.32 (SD = 0.34) m/s for the SWIFT Cast group. Follow-up walking speed was 0.53 (SD = 0.38) m/s for the CPT group and 0.43 (0.34) m/s for the SWIFT Cast group. Differences, after accounting for minimization factors, were insignificant at outcome (P = .345) and follow-up (P = .360).

Conclusion and implications

SWIFT Cast did not enhance the benefit of CPT, but the control group had greater use of another AFO. However, SWIFT Cast remains a clinical option because it is low cost and custom-made by therapists who can readily adapt it during the rehabilitation period.

SUBMITTER: Pomeroy VM

PROVIDER: S-EPMC4704299 | biostudies-literature | 2016 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A Randomized Controlled Evaluation of the Efficacy of an Ankle-Foot Cast on Walking Recovery Early After Stroke: SWIFT Cast Trial.

Pomeroy Valerie M VM Rowe Philip P Clark Allan A Walker Andrew A Kerr Andrew A Chandler Elizabeth E Barber Mark M Baron Jean-Claude JC

Neurorehabilitation and neural repair 20150430 1

<h4>Background</h4>Timely provision of an ankle-foot orthosis (AFO) orthotist customized for individuals early after stroke can be problematic.<h4>Objective</h4>To evaluate the efficacy of a therapist-made AFO (SWIFT Cast) for walking recovery.<h4>Methods</h4>This was a randomized controlled, observer-blind trial. Participants (n = 105) were recruited 3 to 42 days poststroke. All received conventional physical therapy (CPT) that included use of "off-the-shelf" and orthotist-made AFOs. People all ...[more]

PMID: 25931239

Similar Datasets

Project description:We conducted a meta-analysis to investigate the effectiveness of ankle-foot orthosis (AFO) use in improving gait biomechanical parameters such as walking speed, mobility, and kinematics in patients with stroke with gait disturbance. We searched the MEDLINE (Medical Literature Analysis and Retrieval System Online), CINAHL (Cumulative Index to Nursing and Allied Health Literature), Cochrane, Embase, and Scopus databases and retrieved studies published until June 2021. Experimental and prospective studies were included that evaluated biomechanics or kinematic parameters with or without AFO in patients with stroke. We analyzed gait biomechanical parameters, including walking speed, mobility, balance, and kinematic variables, in studies involving patients with and without AFO use. The criteria of the Cochrane Handbook for Systematic Reviews of Interventions were used to evaluate the methodological quality of the studies, and the level of evidence was evaluated using the Research Pyramid model. Funnel plot analysis and Egger's test were performed to confirm publication bias. A total of 19 studies including 434 participants that reported on the immediate or short-term effectiveness of AFO use were included in the analysis. Significant improvements in walking speed (standardized mean difference [SMD], 0.50; 95% CI 0.34-0.66; P < 0.00001; I2, 0%), cadence (SMD, 0.42; 95% CI 0.22-0.62; P < 0.0001; I2, 0%), step length (SMD, 0.41; 95% CI 0.18-0.63; P = 0.0003; I2, 2%), stride length (SMD, 0.43; 95% CI 0.15-0.71; P = 0.003; I2, 7%), Timed up-and-go test (SMD, - 0.30; 95% CI - 0.54 to - 0.07; P = 0.01; I2, 0%), functional ambulation category (FAC) score (SMD, 1.61; 95% CI 1.19-2.02; P < 0.00001; I2, 0%), ankle sagittal plane angle at initial contact (SMD, 0.66; 95% CI 0.34-0.98; P < 0.0001; I2, 0%), and knee sagittal plane angle at toe-off (SMD, 0.39; 95% CI 0.04-0.73; P = 0.03; I2, 46%) were observed when the patients wore AFOs. Stride time, body sway, and hip sagittal plane angle at toe-off were not significantly improved (p = 0.74, p = 0.07, p = 0.07, respectively). Among these results, the FAC score showed the most significant improvement, and stride time showed the lowest improvement. AFO improves walking speed, cadence, step length, and stride length, particularly in patients with stroke. AFO is considered beneficial in enhancing gait stability and ambulatory ability.

Project description:Background: Somatosensory stimulation of the lower extremity could improve motor recovery and walking post-stroke. This pilot study investigated the feasibility of a subsequent randomized controlled trial (RCT) to determine whether task-specific gait training is more effective following either (a) intensive hands-on somatosensory stimulation or (b) wearing textured insoles. Objectives: Determine recruitment and attrition rates, adherence to intervention, acceptability and viability of interventions and outcome measures, and estimate variance of outcome data to inform sample size for a subsequent RCT. Methods: Design: randomized, single-blinded, mixed-methods pilot study. Setting: In-patient rehabilitation ward and community. Participants: n = 34, 18+years, 42-112 days following anterior or posterior circulation stroke, able to follow simple commands, able to walk independently pre-stroke, and providing informed consent. Intervention: Twenty 30-min sessions of task-specific gait training (TSGT) (delivered over 6 weeks) in addition to either: (a) 30-60 min mobilization and tactile stimulation (MTS); or (b) unlimited textured insole (TI) wearing. Outcomes: Ankle range of movement (electrogoniometer), touch-pressure sensory thresholds (Semmes Weinstein Monofilaments), motor impairment (Lower Extremity Motricity Index), walking ability and speed (Functional Ambulation Category, 5-m walk test, pressure insoles) and function (modified Rivermead Mobility Index), measured before randomization, post-intervention, and 1-month thereafter (follow-up). Adherence to allocated intervention and actual dose delivered (fidelity) were documented in case report forms and daily diaries. Focus groups further explored acceptability of interventions and study experience. Analysis: Recruitment, attrition, and dose adherence rates were calculated as percentages of possible totals. Thematic analysis of daily diaries and focus group data was undertaken. Standard deviations of outcome measures were calculated and used to inform a sample size calculation. Results: Recruitment, attrition, and adherence rates were 48.57, 5.88, and 96.88%, respectively. Focus groups, daily-diaries and case report forms indicated acceptability of interventions and outcome measures to participants. The 5-m walk was selected as primary outcome measure for a future trial [mean (SD) at end of intervention: 16.86 (11.24) MTS group and 21.56 (13.57) TI group]; sample size calculation indicated 60 participants are required per group. Conclusion: Recruitment, attrition and adherence rates and acceptability of interventions and outcomes justify a subsequent powered RCT of MTS+TSGT compared with TI+TSGT.

Project description:ObjectivesTo estimate the cost-effectiveness of using a removable boot versus a cast following ankle fracture from the National Health Service and Personal Social Services (NHS+PSS) payer and societal perspectives and explore the impact of both treatments on participants' activities of daily living.DesignCost-effectiveness analyses and qualitative interviews performed alongside a pragmatic multicentre randomised controlled trial.SettingEight UK NHS secondary care trusts.Participants243 participants (60.5% female, on average 48.2 years of age (SD 16.4)) with ankle fracture. Qualitative interviews with 16 participants. Interventions removable air boot versus plaster cast 2 weeks after surgery weight bearing as able with group-specific exercises.Primary and secondary outcome measuresQuality-adjusted life years (QALYs) estimated from the EQ-5D-5L questionnaire, costs and incremental net monetary benefit statistics measured 12 weeks after surgery, for a society willing-to-pay £20 000 per QALY.ResultsCare in the boot group cost, on average, £88 (95% CI £22 to £155) per patient more than in the plaster group from the NHS+PSS perspective. When including all societal costs, the boot saved, on average, £676 per patient (95% CI -£337 to £1689). Although there was no evidence of a QALY difference between the groups (-0.0020 (95% CI -0.0067 to 0.0026)), the qualitative findings suggest participants felt the boot enhanced their quality of life. Patients in the boot felt more independent and empowered to take on family responsibilities and social activities.ConclusionsWhile the removable boot is slightly more expensive than plaster cast for the NHS+PSS payer at 12 weeks after surgery, it reduces productivity losses and the need for informal care while empowering patients. Given that differences in QALYs and costs to the NHS are small, the decision to use a boot or plaster following ankle surgery could be left to patients' and clinicians' preferences.Trial registration numberISRCTN15497399, South Central-Hampshire A Research Ethics Committee (reference 14/SC/1409).

Dataset Information

A Randomized Controlled Evaluation of the Efficacy of an Ankle-Foot Cast on Walking Recovery Early After Stroke: SWIFT Cast Trial.

Background

Objective

Methods

Results

Conclusion and implications

Publications

A Randomized Controlled Evaluation of the Efficacy of an Ankle-Foot Cast on Walking Recovery Early After Stroke: SWIFT Cast Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets