View clinical trials related to Spasticity, Muscle.
Filter by:This study is based on a 4-week double-blind, randomized, controlled, parallel design investigation to investigate the impact of intermittent negative pressure on spasticity and pain in people with multiple sclerosis (pwMS) (NCT05562453). The investigational device (FlowOx2.0™) is composed of a Pressure Chamber and a Control Unit (and disposable parts). All subjects will receive the same pressure chamber but be randomized to either a Control Unit that generates intermittent negative pressure (INP) of - (minus) 40 mmHg or a Control Unit that generates INP of - 10 mmHg. FlowOx2.0™ generating -40 mmHg is the investigational device, and FlowOx2.0™ generating -10 mmHg, is the comparator device. After the initial 4-week double-blind period (NCT05562453), all participants will be offered the -40mmHg control unit to be used during a 6-months optional extension part. The participants who volunteer to continue in the 6-months optional extension part will be included in this study.
The proposed clinical trial will employ the NEUROExos Elbow Module (NEEM), an active robotic exoskeleton, for the passive mobilization and active training of elbow flexion and extension in 60 sub-acute and chronic stroke patients with motor impairments (hemiparesis and/or spasticity) of the right arm. The study protocol is a randomized controlled trial consisting of a 4-week functional rehabilitation program, with both clinical and robotically instrumented assessments to be conducted at baseline and post-treatment.
Spasticity - a variety of motor over-activity and part of the upper motor neuron syndrome - is a common cause of impaired motor function after brain injuries of different etiologies. In addition, it may cause pain and impaired hygiene, contractures, deformities etc. Spasticity has been reported in 30 to 90% of patients with stroke, traumatic brain injury (TBI), incomplete spinal cord injury (SCI) and cerebral palsy (CP). Spasticity therapy has emerged as an important approach to alleviate related symptoms. Positive effects on spasticity are well recognized following systemic and intra-thecal pharmacological treatment, as well as after intra-muscularly injected substances; the effect of the latter is, however, of limited duration. While pharmacological spasticity therapy has been applied for decades, surgical procedures remain fairly uncommon in adults with spasticity, but not in pediatric patients with CP, and outcomes after surgical treatment are scarcely described in the literature. The study center is a specialized unit initially focused on reconstructive as well as spasticity reducing surgery in the upper extremities for SCI patients. Subsequently, patients with spasticity also due to various other Central nervous system diseases have been referred to the center for surgical treatment. Studies describing the effect of spasticity-reducing surgery in the upper extremities are rare and the group is heterogeneous. The aim of the study is therefore to evaluate the results and compare against todays golden standard treatment (boutuliniumtoxin injections).
1. Assessing whether the treatment diary can help optimize the overall treatment of patients. 2. To assess whether the patient finds the treatment diary useful and worth spending time on. Also if the patient finds it easier to evaluate the treatment and, if necessary, set new goals. 3. To assess whether the patient's quality of life is increased by the use of the treatment diary.