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

Primary Purpose

Spasticity, Muscle, Spinal Cord Injuries, Traumatic Brain Injury

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Hand surgery and intensive rehabilitation
Sponsored by
Vastra Gotaland Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spasticity, Muscle

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sahlgrenska University Hospital, centrum for advanced reconstruction of extremities

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Hand surgery and intensive rehabilitation

Botulinum toxin injections

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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 is being assessed with goniometry
to measure joint resting position and passive and active range of motion (ROM). Higher numbers indicates better outcomes
Change is being assessed with Jamar dynamometer
grip strength, higher scores indicates better outcomes
Change is being assessed with pinch gauge
measuring strength in the two- point tip- and lateral key-pinch, Higher scores indicates better outcomes
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 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 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 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 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 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

Full Information

First Posted
March 6, 2019
Last Updated
April 26, 2022
Sponsor
Vastra Gotaland Region
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1. Study Identification

Unique Protocol Identification Number
NCT03910101
Brief Title
The Effect of Spasticity-correcting Hand Surgery for Spasticity Related Symptoms
Official Title
The Effect of Spasticity-correcting Hand Surgery for Spasticity Related Symptoms After Neurological Injuries - a Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 30, 2019 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
November 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vastra Gotaland Region

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spasticity, Muscle, Spinal Cord Injuries, Traumatic Brain Injury, Stroke, Upper Extremity Paresis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hand surgery and intensive rehabilitation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Botulinum toxin injections
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Hand surgery and intensive rehabilitation
Other Intervention Name(s)
Botulinum toxin injections and rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change is being assessed with Modified Ashworth Scale
Description
0-5 scale that quantify the degree of resistance to passive movement of the target muscle group
Time Frame
Change from baseline and at the the time points 4-6weeks and 6months
Secondary Outcome Measure Information:
Title
Change is being assessed with Visual Analog scale (VAS)
Description
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.
Time Frame
Change from baseline and at the the time points 4-6weeks and 6months
Title
Change is being assessed with goniometry
Description
to measure joint resting position and passive and active range of motion (ROM). Higher numbers indicates better outcomes
Time Frame
Change from baseline and at the the time points 4-6weeks and 6months
Title
Change is being assessed with Jamar dynamometer
Description
grip strength, higher scores indicates better outcomes
Time Frame
Change from baseline and at the the time points 4-6weeks and 6months
Title
Change is being assessed with pinch gauge
Description
measuring strength in the two- point tip- and lateral key-pinch, Higher scores indicates better outcomes
Time Frame
Change from baseline and at the the time points 4-6weeks and 6months
Title
Change is being assessed with opening of the hand passive, Active and resting position
Description
Five step scale that goes from closed, 1/4 opened, 1/2 opened, 3/4 opened, open hand. Higher scores indicates better outcomes.
Time Frame
Change from baseline and at the the time points 4-6weeks and 6months
Title
Change is being assessed with The Canadian Occupational Performance Measure (COPM)
Description
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.
Time Frame
Change from baseline and at the the time points 4-6weeks and 6months
Title
Change is being assessed with Grasp and Release Test (GRT)
Description
assessing the patients' ability to grasp, move, and release 6 objects of varying weight and size during 30 seconds. Higher scores indicates better outcomes.
Time Frame
Change from baseline and at the the time points 4-6weeks and 6months
Title
Change is being assessed with Arm Activity Measure (ArmA)
Description
a patient reported outcome measure of active and passive function in the hemiparetic upper limb. Lower scores indicates better outcomes.
Time Frame
Change from baseline and at the the time points 4-6weeks and 6months
Title
Change is being assessed with Cylinder test
Description
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.
Time Frame
Change from baseline and at the the time points 4-6weeks and 6months
Title
Change is being assessed with Functional score
Description
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
Time Frame
Change from baseline and at the the time points 4-6weeks and 6months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lina Bunketorp Kall, PhD
Organizational Affiliation
University of Gothenburg, Sahlgrenska academy
Official's Role
Study Chair
Facility Information:
Facility Name
Sahlgrenska University Hospital, centrum for advanced reconstruction of extremities
City
Mölndal
State/Province
Västra Götaland
ZIP/Postal Code
431 30
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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

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