Will patients with severe acquired brain injury develop abnormal joint positions and reduced mobility during hospitalisation at a neurorehabilitation department?

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN17910097

Enrollment

Registered

2017-09-12

Start date

2014-07-02

Completion date

Unknown

Last updated

2020-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe aquired brain injury Injury, Occupational Diseases, Poisoning Severe aquired brain injury

Interventions

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 b

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Denmark

Contacts

Public ContactMathilde Kofoed-Hansen

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 20, 2026