Enhancing sensory acuity and balance function using near-sensory biofeedback-based perturbation intervention for individuals with traumatic brain injury.

BACGROUND: Interventions addressing balance dysfunction after traumatic brain injury (TBI) only target compensatory aspects and do not investigate perceptual mechanisms such as sensory acuity. OBJECTIVE: To evaluate the efficacy of a novel intervention that integrates sensory acuity with a perturbation-based approach for improving the perception and functional balance after TBI. METHODS: A two-group design was implemented to evaluate the effect of a novel, perturbation-based balance intervention. The intervention group (n = 5) performed the intervention with the sinusoidal (0.33, 0.5, and 1 Hz) perturbations to the base of support with amplitudes derived using our novel outcome of sensory acuity - perturbation perception threshold (PPT). The efficacy is evaluated using changes in PPT and functional outcomes (Berg Balance Scale (BBS), Timed-up and Go (TUG), 5-meter walk test (5MWT), and 10-meter walk test (10MWT)). RESULTS: There was a significant post-intervention change in PPT for 0.33 Hz (p = 0.021). Additionally, clinically and statistically significant improvements in TUG (p = 0.03), 5MWT (p = 0.05), and 10MWT (p = 0.04) were observed. CONCLUSIONS: This study provides preliminary efficacy of a novel, near-sensory balance intervention for individuals with TBI. The use of PPT is suggested for a comprehensive understanding and treatment of balance dysfunction. The promising results support the investigation in a larger cohort.

Improving Perception of Perturbations and Balance Using a Novel Dynamic Computerized Biofeedback Based Intervention after Traumatic Brain Injury.

Traumatic Brain Injury (TBI) impairs the integration and organization of the visual, auditory, and somatosensory inputs that permit body position awareness in relation to self and environment resulting in balance dysfunction (BD). The sensitivity levels to which the environmental perturbations are perceived are also critical for attaining the position awareness and the equilibrium. Undetectable perturbations, however small they may be, can result in fatal falls, especially after TBI. In this investigation, we used a novel dynamic computerized biofeedback based (CBB) intervention aimed at improving the perception of external perturbations, and static and dynamic balance in individuals with TBI. The effect of the CBB intervention on balance was accessed using a clinical measure - Berg Balance Scale (BBS), a novel psychophysical measure - perception of perturbation threshold (PPT), and biomechanical measures derived from center of pressure (COP) data during controlled sinusoidal varied-amplitudes anterior-posterior perturbations of 0.33 Hz, 0.5 Hz, and 1 Hz to the base of support. At baseline, the TBI-Control (TBI-C) group (n=5) and the TBI-Intervention (TBI-I) group (n=2) showed impaired balance compared to the healthy control (HC) group (n=5). This was shown by lower BBS and elevated values of PPT and COP measures (RMS COP, COP velocity, Phase Plane Indices (PPI)). Post CBB intervention, TBI-I group showed increased BBS and reduction in PPTs, COP measures (velocity and PPI), suggesting improvements in postural stability and balance. This investigation explores a potential link between the perception of perturbations and balance and demonstrates the applicability of the CBB intervention for improving interpretation and organization of multisensory information in a task-specific environment to improve balance post-TBI.

Postural responses after utilization of a computerized biofeedback based intervention aimed at improving static and dynamic balance in traumatic brain injury: a case study.

Balance dysfunction is one of the most disabling aspects of Traumatic Brain Injury (TBI). Without rapid transmission and accurate perception of somatosensory inputs, the automatic postural responses required during standing may be delayed or absent after TBI which can lead to instability. Further, the sensitivity level to which environmental perturbations can be detected is also vital, as the central nervous system will only employ balance control strategies when it perceives a change in equilibrium. Such undetectable perturbations, however small they may be, can result in fatal falls, especially after TBI. In this investigation we used a novel computerized biofeedback based (CBB) intervention aimed at improving perception of external perturbations, and static and dynamic balance in a single male participant with severe TBI. We used an adaptive single interval adjustment matrix (SIAM) protocol to determine the perception of perturbation threshold (PPT) at baseline (1 day pre-intervention) and follow up (1 day post-intervention). External perturbations were provided through sinusoidal translations of 0.5 Hz to the base of support in anterior-posterior direction. Outcome measures included PPT, the Berg balance scale (BBS) and bilateral surface electromyography (EMG) of the lower limbs at baseline and follow up. PPT assessment post intervention showed a decrease in PPT, suggesting an improvement in the ability (gain of 0.42 mm) to detect (even smaller) perturbations which were not perceivable prior to the intervention. There was a significant increase in BBS (6 points) at follow up. The participant demonstrated increased muscle activation for the right gastrocnemius, left soleus, right bicep femoris and left vastus lateralis muscles at follow up. This investigation demonstrate the potential use of the CBB intervention for improving interpretation and organization of multisensory information in a task specific environment to improve balance dysfunction post TBI.

Long-Term Follow-up to a Randomized Controlled Trial Comparing Peroneal Nerve Functional Electrical Stimulation to an Ankle Foot Orthosis for Patients With Chronic Stroke.

BACKGROUND: Evidence supports peroneal nerve functional electrical stimulation (FES) as an effective alternative to ankle foot orthoses (AFO) for treatment of foot drop poststroke, but few long-term, randomized controlled comparisons exist. OBJECTIVE: Compare changes in gait quality and function between FES and AFOs in individuals with foot drop poststroke over a 12-month period. METHODS: Follow-up analysis of an unblinded randomized controlled trial (ClinicalTrials.gov #NCT01087957) conducted at 30 rehabilitation centers comparing FES to AFOs over 6 months. Subjects continued to wear their randomized device for another 6 months to final 12-month assessments. Subjects used study devices for all home and community ambulation. Multiply imputed intention-to-treat analyses were utilized; primary endpoints were tested for noninferiority and secondary endpoints for superiority. Primary endpoints: 10 Meter Walk Test (10MWT) and device-related serious adverse event rate. Secondary endpoints: 6-Minute Walk Test (6MWT), GaitRite Functional Ambulation Profile, and Modified Emory Functional Ambulation Profile (mEFAP). RESULTS: A total of 495 subjects were randomized, and 384 completed the 12-month follow-up. FES proved noninferior to AFOs for all primary endpoints. Both FES and AFO groups showed statistically and clinically significant improvement for 10MWT compared with initial measurement. No statistically significant between-group differences were found for primary or secondary endpoints. The FES group demonstrated statistically significant improvements for 6MWT and mEFAP Stair-time subscore. CONCLUSIONS: At 12 months, both FES and AFOs continue to demonstrate equivalent gains in gait speed. Results suggest that long-term FES use may lead to additional improvements in walking endurance and functional ambulation; further research is needed to confirm these findings.

EMG of the tibialis anterior demonstrates a training effect after utilization of a foot drop stimulator.

BACKGROUND: Functional Electrical Stimulation (FES) applied through a foot drop stimulator (FDS) is a rehabilitation intervention that can stimulate the common peroneal nerve to provide dorsiflexion at the correct timing during gait. OBJECTIVE: To determine if FES applied to the peroneal nerve during walking through a FDS would effectively retrain the electromyographic temporal activation of the tibialis anterior in individuals with stroke. METHODS: Surface electromyography (EMG) were collected bilaterally from the tibialis anterior (TA) while participants (n = 4) walked with and without the FDS at baseline and 4 weeks. Comparisons were made between stimulation timing and EMG activation timing to produce a burst duration similarity index (BDSI). RESULTS: At baseline, participants displayed variable temporal activation of the TA. At 4 weeks, TA activation during walking without the FDS more closely resembled the pre-programmed FDS timing demonstrated by an increase in BDSI scores in all participants (P = 0.05). CONCLUSIONS: Continuous use of FDS during a task specific movement can re-train the neuromuscular system. After 4 weeks of utilization the FDS trained the TA to replicate the programmed temporal activation patterns. These findings begin to establish the FDS as a rehabilitation intervention that may facilitate recovery rather than just compensate for stroke related gait impairments due to foot drop.

The effects of peroneal nerve functional electrical stimulation versus ankle-foot orthosis in patients with chronic stroke: a randomized controlled trial.

BACKGROUND: Evidence supports peroneal nerve functional electrical stimulation (FES) as an effective alternative to ankle-foot orthoses (AFO) for treatment of foot drop poststroke, but few randomized controlled comparisons exist. OBJECTIVE: To compare changes in gait and quality of life (QoL) between FES and an AFO in individuals with foot drop poststroke. METHODS: In a multicenter randomized controlled trial (ClinicalTrials.gov #NCT01087957) with unblinded outcome assessments, 495 Medicare-eligible individuals at least 6 months poststroke wore FES or an AFO for 6 months. Primary endpoints: 10-Meter Walk Test (10MWT), a composite of the Mobility, Activities of Daily Living/Instrumental Activities of Daily Living, and Social Participation subscores on the Stroke Impact Scale (SIS), and device-related serious adverse event rate. Secondary endpoints: 6-Minute Walk Test, GaitRite Functional Ambulation Profile (FAP), Modified Emory Functional Ambulation Profile (mEFAP), Berg Balance Scale (BBS), Timed Up and Go, individual SIS domains, and Stroke-Specific Quality of Life measures. Multiply imputed intention-to-treat analyses were used with primary endpoints tested for noninferiority and secondary endpoints tested for superiority. RESULTS: A total of 399 subjects completed the study. FES proved noninferior to the AFO for all primary endpoints. Both the FES and AFO groups improved significantly on the 10MWT. Within the FES group, significant improvements were found for SIS composite score, total mFEAP score, individual Floor and Obstacle course time scores of the mEFAP, FAP, and BBS, but again, no between-group differences were found. CONCLUSIONS: Use of FES is equivalent to the AFO. Further studies should examine whether FES enables better performance in tasks involving functional mobility, activities of daily living, and balance.

Effect of a foot-drop stimulator and ankle-foot orthosis on walking performance after stroke: a multicenter randomized controlled trial.

BACKGROUND: Studies have demonstrated the efficacy of functional electrical stimulation in the management of foot drop after stroke. OBJECTIVE: To compare changes in walking performance with the WalkAide (WA) foot-drop stimulator and a conventional ankle-foot orthosis (AFO). METHODS: Individuals with stroke within the previous 12 months and residual foot drop were enrolled in a multicenter, randomized controlled, crossover trial. Subjects were assigned to 1 of 3 parallel arms for 12 weeks (6 weeks/device): arm 1 (WA-AFO), n = 38; arm 2 (AFO-WA), n = 31; arm 3 (AFO-AFO), n = 24. Primary outcomes were walking speed and Physiological Cost Index for the Figure-of-8 walking test. Secondary measures included 10-m walking speed and perceived safety during this test, general mobility, and device preference for arms 1 and 2 for continued use. Walking tests were performed with (On) and without a device (Off) at 0, 3, 6, 9, and 12 weeks. RESULTS: Both WA and AFO had significant orthotic (On-Off difference), therapeutic (change over time when Off), and combined (change over time On vs baseline Off) effects on walking speed. An AFO also had a significant orthotic effect on Physiological Cost Index. The WA had a higher, but not significantly different therapeutic effect on speed than an AFO, whereas an AFO had a greater orthotic effect than the WA (significant at 12 weeks). Combined effects on speed after 6 weeks did not differ between devices. Users felt as safe with the WA as with an AFO, but significantly more users preferred the WA. CONCLUSIONS: Both devices produce equivalent functional gains.