Botulinum Toxin for the Upper Limb After Stroke (BoTULS) Trial (original) (raw)
Related papers
Trials, 2014
Background: Patients surviving stroke but who have significant impairment of function in the affected arm are at more risk of developing pain, stiffness and contractures. The abnormal muscle activity, associated with post-stroke spasticity, is thought to be causally associated with the development of these complications. Treatment of spasticity is currently delayed until a patient develops signs of these complications. Methods/Design: This protocol is for a phase II study that aims to identify whether using OnabotulinumtoxinA (BoNT-A) in combination with physiotherapy early post stroke when initial abnormal muscle activity is neurophysiologically identified can prevent loss of range at joints and improve functional outcomes. The trial uses a screening phase to identify which people are appropriate to be included in a double blind randomised placebo-controlled trial. All patients admitted to Sandwell and West Birmingham NHS Trust Hospitals with a diagnosis of stroke will be screened to identify functional activity in the arm. Those who have no function will be appropriate for further screening. Patients who are screened and have abnormal muscle activity identified on EMG will be given electrical stimulation to forearm extensors for 3 months and randomised to have either injections of BoNT-A or normal saline. The primary outcome measure is the action research arm test-a measure of arm function. Further measures include spasticity, stiffness, muscle strength and fatigue as well as measures of quality of life, participation and caregiver strain.
Botulinum toxin type A for the treatment of arm and hand spasticity in stroke patients
Clinical Rehabilitation, 1997
Background: Focal spasticity can be a major drawback in the rehabilitation of stroke patients. Previous studies suggest a beneficial effect for botulinum toxin A (BTX-A) for relief of spasticity. Objective: To evaluate the safety and efficacy of BTX-A in the treatment of spasticity in a homogeneous group of stroke patients. Methods: In this phase III open label trial 19 stroke patients stable for at least six months were enrolled (mean age 53.1 (SD 3.27) years; range 26-72). There were 16 males and 4 females. Assessments: Clinical (Ashworth spasticity rating scale, scores for joint mobility, pain and frequency of spasms, Frenchay arm test (FAT)) and subjective (semi-quantitative rating scale filled out by the patient). Only hand and finger flexors were injected. The maximum dosage was 150 U BOTOX® (25 U/muscle), the mean dosage was 92.1 ± 31.6 U BOTOX®. Results: Ashworth rating scale and joint mobility scores improved from a median value of 2 at baseline to a median value of 1 one m...
Neurological Sciences, 2005
Current antispastic medications are unsatisfactory for spasticity treatment, but botulinum toxin type A (BTX-A) shows promise as a new therapeutic option. This open-label, prospective study aimed to assess the effectiveness of BTX-A in improving functional mobility in the early post-stroke population using an individualised, flexible range of doses and targeted muscle groups. Twenty-one stroke patients (13 male, 8 female) were enrolled and injected with BTX-A (Botox, Allergan, mean dose: 255 U; range: 185-300) according to individual spasticity patterns. Assessments were made at baseline and weeks 2, 4,
Health technology assessment (Winchester, England), 2010
To compare the clinical effectiveness and cost-effectiveness of treating upper limb spasticity due to stroke with botulinum toxin type A plus an upper limb therapy programme with the upper limb therapy programme alone. A multicentre open-label parallel-group randomised controlled trial and economic evaluation. Twelve stroke services in the north of England, UK. Three hundred and thirty-three adults with upper limb spasticity at the shoulder, elbow, wrist or hand and reduced upper limb function due to stroke more than 1 month previously. The intervention group received botulinum toxin type A injection(s) plus a 4-week programme of upper limb therapy. The control group received the upper limb therapy programme alone. Participants were clinically reassessed at 3, 6 and 9 months to determine the need for repeat botulinum toxin type A injection(s) and/or therapy. The primary outcome was upper limb function 1 month after study entry measured by the Action Research Arm Test (ARAT). A succe...
Journal of Rehabilitation Medicine, 2009
Objective: Botulinum toxin is known to relieve upper limb spasticity, which is a disabling complication of stroke. We examined its effect on quality of life and other person-centred perspectives. Design: A multi-centre, randomized, double-blind, placebocontrolled study. Patients: Ninety-six patients were randomized (mean age 59.5 years) at least 6 months post-stroke. Mean time since stroke was 5.9 years. Methods: Patients received either botulinum toxin type A or placebo into the affected distal upper limb muscles on 2 occasions, 12 weeks apart. Assessment was undertaken at baseline, 8, 12, 20 and 24 weeks. The primary outcome measure was the Assessment of Quality of Life scale (AQoL). Secondary outcome assessments included Goal Attainment Scaling (GAS), pain, mood, global benefit, Modified Ashworth Scale (MAS), disability and carer burden. Results: The groups did not differ significantly with respect to quality of life, pain, mood, disability or carer burden. However, patients treated with botulinum toxin type A had significantly greater reduction in spasticity (MAS) (p < 0.001), which translated into higher GAS scores (p < 0.01) and greater global benefit (p < 0.01). Conclusion: Although no change in quality of life was demonstrated using the AQoL, botulinum toxin type A was found to be safe and efficacious in reducing upper limb spasticity and improving the ability to achieve personal goals.
BMC Neurology
Background It is common for people with persistent spasticity due to a stroke to receive an injection of botulinum toxin-A in the upper limb, however post-injection intervention varies. Aim To determine the long-term effect of additional upper limb rehabilitation following botulinum toxin-A in chronic stroke. Method An analysis of long-term outcomes from national, multicenter, Phase III randomised trial with concealed allocation, blinded measurement and intention-to-treat analysis was carried out. Participants were 140 stroke survivors who were scheduled to receive botulinum toxin-A in any muscle(s) that cross the wrist because of moderate to severe spasticity after a stroke greater than 3 months ago, who had completed formal rehabilitation and had no significant cognitive impairment. Experimental group received botulinum toxin-A plus 3 months of evidence-based movement training while the control group received botulinum toxin-A plus a handout of exercises. Primary outcomes were goa...
Life
Our purpose is to emphasize the role of botulinum toxin in spasticity therapy and functional recovery in patients following strokes. Our retrospective study compared two groups, namely ischemic and hemorrhagic stroke patients. The study group (BT group) comprised 80 patients who received focal botulinum toxin as therapy for an upper limb with spastic muscle three times every three months. The control group (ES group) comprised 80 patients who received only medical rehabilitation consisting of electrostimulation and radial shockwave therapy for the upper limb, which was applied three times every three months. Both groups received the same stretching program for spastic muscles as a home training program. We evaluated the evolution of the patients using muscle strength, Ashworth, Tardieu, Frenchay, and Barthel scales. The analysis indicated a statistically significant difference between the two groups for all scales, with better results for the BT group (p < 0.0001 for all scales)....
Neurology international, 2018
The aim was to investigate if botulinum toxin type A (BTx-A) associated with physical therapy is superior to physical therapy alone in post stroke spasticity. A randomized, double-blinded controlled trial was performed in a rehabilitation unit on Northeastern, Brazil. Patients with post stroke spasticity were enrolled either to BTx-A injections and a pre-defined program of physical therapy or saline injections plus physical therapy. Primary endpoint was functional performance evaluated through time up and go test, six minutes walking test and Fugl-Meyer scale for upper limb. Secondary endpoint was spasticity improvement. Confidence interval was considered at 95%. Although there was a significant decrease in upper limbs flexor tonus (P<0.05) in the BTx-A group, there was no difference regarding functional performance after 9 months of treatment. When analyzing gait speed and performance, both groups showed a significant improvement in the third month of treatment, however it was n...