Condition category
Injury, Occupational Diseases, Poisoning
Date applied
05/09/2017
Date assigned
12/09/2017
Last edited
11/09/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
Increased resistance when a joint is moved slowly (passive ankle joint stiffness), increased resistance with exaggerated muscle activity when the muscle is stretched at high velocity (spasticity) and decreased joint mobility (contractures) are common symptoms in patients with a brain injury. These symptoms may lead to increased joint stiffness, abnormal joint positions, reduced physical performance and pain. Currently, these symptoms are treated with physiotherapy and antispastic medication. Some challenges, however, exist for the correct diagnosis, choice of treatment strategies, and measurement of the outcome of such strategies. Current scoring scales are, however, unable to adequately measure and discriminate between the different components of reduced joint mobility. Furthermore, it is not clear whether current treatment strategies prevent stiffness, spasticity or contractures. The aim of this study is to make a biomechanical evaluation of the occurrence of spasticity, stiffness and contractures in patients with severe acquired brain injuries.

Who can participate?
Adults (age 18 or older) with severe acquired brain injuries and paresis or paralysis in the lower extremities.
Healthy adults (age 18 or older) with no history of neurological disease or fractures of the lower extremities.

What does the study involve?
Participants are recruited after admission to the department. Participants are tested for their muscle tone and spasticity and provide a blood sample. Participants are also given a portable device to wear on their foot and are asked to performed stretches in both of their left and right ankles. This assesses their ankle joint function. Participants are monitored throughout their hospitalisation and have a follow-up measurement one year after the injury date.

What are the possible benefits and risks of participating?
There are no notable benefits or risks of participating.

Where is the study run from?
Department of Neurorehabilitation, Traumatic Brain Injury, Rigshospitalet (Denmark)

When is the study starting and how long is it expected to run for?
November 2014 to February 2017

Who is funding the study?
1. Institute Produits Synthèse (IPSEN) (Denmark)
2. Association of Danish Physiotherapists (Denmark)

Who is the main contact?
Mathilde Kofoed-Hansen
mkh@movotec.dk

Trial website

Contact information

Type

Public

Primary contact

Miss Mathilde Kofoed-Hansen

ORCID ID

http://orcid.org/0000-0002-1364-795X

Contact details

Elsass Institute
Holmegaardsvej 28
Charlottenlund
Charlottenlund
2920
Denmark

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Occurrence of passive ankle joint stiffness, spasticity and contractures in patients with severe aquired brain injury

Acronym

Study hypothesis

With biomechanical measurements of muscle function it is possible to evaluate muscle function objectively and distinguish the different components of muscle tonus.

Ethics approval

Ethics Committee of Copenhagen Denmark, 07/01/2014, ref: H-2-2014-058

Study design

Prospective cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

No participant information sheet available

Condition

Severe aquired brain injury

Intervention

Both healthy adults and adults with severe acquired brain injury are included in this study. Participants are allocated to either the group of patients, if they were diagnosed with a severe acquired brain injury and admitted to the neurorehabilitation ward, or to the group of healthy controls. The group of healthy controls are recruited.

Group 1 Patients with severe acquired brain injury:
Participants in this group attend one test session every week during hospitalization after admission to the neurorehabilitation ward. Furthermore they attend one test session one year after injury date. The total duration of each session is approximately one hour. The test session consists of a subjective, clinical tool to measure spasticity, the Modified Ashworth Scale (MAS) and an objective evalutation of passive and reflex mediated stiffness in the ankle joint plantar flexors by a hand-held device attached under the foot. The device contains a dynamometer, electromyography, accelerometer and a gyroscope. The patient is lying supine in bed. An experienced clinician performs slow stretches of the ankle joint from a plantar flexed position. Afterwards, fast stretches above the stretch reflex threshold are applied. One test session consists of five slow stretches and five fast stretches of each ankle joint. The purpose of this study is to evaluate the development of contractures, spasticity and ankle joint stiffness in patients admitted to neurorehabilitation. Patients that are included in the study receive the same physiotherapy and medical treatment as other patients at the department.

Group 2 Healthy participants:
Each participant undergo one test session with a duration of approximately one hour. The test procedure is the same as for patients except that healthy participants are not having a subjective clinical evalutation of their muscle tonus (The MAS test).

The group of patients with severe acquired brain injury attended a follow-up test session one year after their injury date.

Intervention type

Device

Phase

Drug names

Primary outcome measures

1. Passive ankle joint stiffness during both slow and fast dorsiflexions is measured using a biomechanical, hand-held device. Patients with severe acquired brain injuries are measured once every week during hospitalization. One year after their injury date, patients will attend one test session. Healthy controls are measured once.
2. Quantification of the occurrence of muscle contractures from measurements of range of motion is measured using “a hand-held device containing a gyroscope”. Measurements are taken once every week during hospitalization and 1 year after the injury. Healthy controls are measured once during one test session.
3. Quantification of the occurrence of spasticity during hospitalization and one year after the injury is measured using the hand-held device and is compared to the clinical measure of spasticity using the MAS test

Secondary outcome measures

1. Changes in collagen types, actin and myosin involved in construction of muscle tissue “are” measured from a blood sample taken from the patients at the first test session during hospitalization and in the beginning of the test session for the healthy controls. Blood samples are analyzed with the Next Generation Sequencing method.
2. Clinical data is measured during hospitalization:
2.1. Functional independence measure (FIM™)
2.2. Early Functional Abilities (EFA)
2.3. Glasgow Come Scale (GCS)
2.4. Glasgow Outcome Scale-Extended (GOS-E)
3. The amount of physiotherapy and any use spasticity reducing medication “are registered in a database by the clinicians with information on date, type and amount of treatment. Information relevant to the study will then be extracted from the database.

Overall trial start date

01/05/2014

Overall trial end date

27/02/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Patients who must meet all of the following inclusion criteria:
1. >18 years
2. Patients with severe aquired brain injury who are admitted to rehabilitation at Department of Neurorehabilitation.
3. Patients with palsy or paralysis in at least one of the lower extremities.

Healthy controls:
1. Healthy adults >18 years

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

Patients: N=32. Healthy controls: N = 15

Participant exclusion criteria

Patients:
1. Patients with fractures of the lower extremities
2. Patients with non-cooperative behavior

Controls:
1. Musculoskeletal disorders.
2. Diabetes Mellitus Type 2.
3. Use of muscle relaxation drugs or neuromuscular blocking agents.

Recruitment start date

02/07/2014

Recruitment end date

17/01/2017

Locations

Countries of recruitment

Denmark

Trial participating centre

Rigshospitalet
Department of Neurorehabilitation, Traumatic Brain Injury Kettegård Allé 30
Hvidovre
2650
Denmark

Sponsor information

Organisation

Rigshospitalet

Sponsor details

Department of Neurorehabilitation
Traumatic Brain Injury
Hvidovre Hospital
Kettegård Allé 30
Hvidovre
2650
Denmark

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Institute Produits Synthèse (IPSEN)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Association of Danish Physiotherapists

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high impact peer reviewed journal.

IPD sharing statement:
Data will be stored at Department of Neurorehabilitation, Rigshospitalet, according to the data protecting law. Data is not intended to be public available. The type of data stored is raw data from the biomechanical, hand-held device including angles and forces. Furthermore, clinical data from clinical questionnaires are stored. All data is anonymized and all patients and participants gave their informed consent to participate and that their anonymized data could be published. Any further information about the data can be provided by request.

Intention to publish date

01/02/2018

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes