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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03910101
• Other study ID #: Theno1RCT
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 30, 2019
• Est. completion date: November 10, 2023

Study information

• Verified date: April 2022
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 34
• Est. completion date: November 10, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Muscle Spasticity
• Paresis
• Spasticity, Muscle
• Spinal Cord Injuries
• Stroke
• Traumatic Brain Injury
• Upper Extremity Paresis
• Wounds and Injuries

Intervention

Procedure:
• Hand surgery and intensive rehabilitation
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.

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital, centrum for advanced reconstruction of extremities	Mölndal	Västra Götaland

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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