The Effect of Spasticity-correcting Hand Surgery for Spasticity Related Symptoms

Study Overview
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Brief Summary
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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).

Official Title
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The Effect of Spasticity-correcting Hand Surgery for Spasticity Related Symptoms After Neurological Injuries - a Randomized Study

Conditions
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Stroke, Spasticity, Muscle, Spinal Cord Injuries, Traumatic Brain Injury, Upper Extremity Paresis

Intervention / Treatment
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* Procedure: Hand surgery and intensive rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Problematic increased muscle tension in upper extremity after stroke, TBI or SCI; At least 6 months from illness / injury; under treatment with botox injection in upper extremity at Högsbo hospital; At least 2 muscles in the hand / wrist should be relevant for treatment; no residual spasticity-reducing effect of botulinum toxin in the body; Medically stable to undergo surgery; No other upper limb injury that affects the individual's level of function; No heavily fixed joint contract. Exclusion Criteria: Under the age of 18

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hand surgery and intensive rehabilitation<br>The surgical treatment for reducing spasticity comprises lengthening of tendons, muscle release and occasionally correction of deformities. Lengthening of a tendon or releasing a muscle from its insertion, results in relaxation of the whole muscle-tendon unit. Hence, the spasticity is not gone, but reduced in strength. The tendon lengthening procedures is performed by a stair-step incision technique followed by reattachment in the lengthened position using a side-to-side, cross-stich technique. The load to failure of the sutured tendon is approximately 200Newton, which gives a sufficient safety margin for early active mobilization of the tendons involved. This suture technique thus enables active training directly after surgery. Postoperative rehabilitation includes wrapping and a custom-made splint, for day and night use, muscle activation and passive stretching 2-4 times per day without the splint. | Procedure: Hand surgery and intensive rehabilitation<br>* Spasticity-correcting upper-limb surgery comprised lengthening of tendons, release of muscles, and occasionally correction of deformities. Rehabilitation starts the first post-operative day and comprised physiotherapy and occupational therapy. Patients are also taught a home-training program. Up to 1 week of intensive in-hospital rehabilitation followed 3 weeks after surgery and a new home-training program are designed.<br>* Other names: Botulinum toxin injections and rehabilitation;|
| Active Comparator: Botulinum toxin injections<br>Botulinum toxin injections are given in spastic muscles of the upper extremity. Dosage and number of injections per muscle vary depending on the degree and extent of spasticity. For optimal effect on hand function, botulinum toxin is accompanied by the treatment of individualized exercise and splinting when needed. | Procedure: Hand surgery and intensive rehabilitation<br>* Spasticity-correcting upper-limb surgery comprised lengthening of tendons, release of muscles, and occasionally correction of deformities. Rehabilitation starts the first post-operative day and comprised physiotherapy and occupational therapy. Patients are also taught a home-training program. Up to 1 week of intensive in-hospital rehabilitation followed 3 weeks after surgery and a new home-training program are designed.<br>* Other names: Botulinum toxin injections and rehabilitation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change is being assessed with Modified Ashworth Scale | 0-5 scale that quantify the degree of resistance to passive movement of the target muscle group | Change from baseline and at the the time points 4-6weeks and 6months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change is being assessed with Visual Analog scale (VAS) | for pain, patient's self-rating of general arm-hand function (usefulness), appearance of the hand and self-rating spasticity. Visual Analog Scale is a straight horizontal line of fixed length, 100 mm. The ends are defined as the extreme limits of the parameter to be measured. Orientated from the left no; pain, spasticity, problem with appearance to the right worst possible; pain, spasticity, problem with appearance. In the general hand function question the scale goes from left side no hand function to the right side best possible hand function. In the pain, spasticity and appearance question a high number indicate a worse outcome, in the general hand function question a high number represent a better outcome. Respondents specify their level of agreement to the statement by indicating a position along the line. | Change from baseline and at the the time points 4-6weeks and 6months | 
| Change is being assessed with goniometry | to measure joint resting position and passive and active range of motion (ROM). Higher numbers indicates better outcomes | Change from baseline and at the the time points 4-6weeks and 6months | 
| Change is being assessed with Jamar dynamometer | grip strength, higher scores indicates better outcomes | Change from baseline and at the the time points 4-6weeks and 6months | 
| Change is being assessed with pinch gauge | measuring strength in the two- point tip- and lateral key-pinch, Higher scores indicates better outcomes | Change from baseline and at the the time points 4-6weeks and 6months | 
| Change is being assessed with opening of the hand passive, Active and resting position | Five step scale that goes from closed, 1/4 opened, 1/2 opened, 3/4 opened, open hand. Higher scores indicates better outcomes. | Change from baseline and at the the time points 4-6weeks and 6months | 
| Change is being assessed with The Canadian Occupational Performance Measure (COPM) | measuring performance and satisfaction of therapy regarding the most important activity limitations due to spasticity (up to 5) as chosen and assessed by the patient on a scale from 1-10, higher number indicates better outcomes. | Change from baseline and at the the time points 4-6weeks and 6months | 
| Change is being assessed with Grasp and Release Test (GRT) | assessing the patients' ability to grasp, move, and release 6 objects of varying weight and size during 30 seconds. Higher scores indicates better outcomes. | Change from baseline and at the the time points 4-6weeks and 6months | 
| Change is being assessed with Arm Activity Measure (ArmA) | a patient reported outcome measure of active and passive function in the hemiparetic upper limb. Lower scores indicates better outcomes. | Change from baseline and at the the time points 4-6weeks and 6months | 
| Change is being assessed with Cylinder test | the test is measuring the opening and grasp ability of the patient's hand. The test evaluate four different way of grasping; normal one hand grip, adapted one hand grip, two hand grip and adapted two hand grip. The test consists cylinders in 15 different sizes from 10mm to 150mm. The cylinder test enables measuring progress of opening the hand during rehabilitation or before and after surgery. Higher scores indicates better outcomes. | Change from baseline and at the the time points 4-6weeks and 6months | 
| Change is being assessed with Functional score | Grade the upper limb function (1-4). Description Absence of useful active mobility and uneasy and painful passive mobilization, making difficult to dress and wash Easy passive mobilization but without any useful voluntary movements Slight but useful voluntary motor function Good active mobility with the possibility of prehension in the hand and fingers. Higher numbers indicates better outcomes | Change from baseline and at the the time points 4-6weeks and 6months |