Is it possible to distinguish different components of ankle joint stiffness in spastic subjects using a portable device?

• Register: ISRCTN
• Last refreshed on: 7 December 2020
• Main ID: ISRCTN14480787
• Date of registration: 16/03/2017
• Prospective Registration: No
• Primary sponsor: Elsass Institute
• Public title: Is it possible to distinguish different components of ankle joint stiffness in spastic subjects using a portable device?
• Scientific title: Distinguishing passive and reflex-mediated ankle joint stiffness in adults with cerebral palsy using a portable device
• Date of first enrolment: 01/04/2014
• Target sample size: 41
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN14480787
• Study type: Observational
• Study design: Observational cross-sectional case-control reliability study (Other)
• Phase: Not Specified

Countries of recruitment

Denmark

Contacts

• Name: Mathilde Kofoed-Hansen

Key inclusion & exclusion criteria

Inclusion criteria:
Healthy volunteer:
Aged 18 or older

Intervention group:
1. Diagnosed with CP
2. Aged 18 or older

Exclusion criteria:
1. History of a neurological disease
2. Fracture in lower limbs
3. Treatment with anti-spastic medication within 12 months prior to the inclusion of the study


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Cerebral Palsy (CP)
Musculoskeletal Diseases
Cerebral Palsy (CP)

Intervention(s)

Both healthy adults and adults with Cerebral Palsy (CP) are included in this study. Participants are allocated to one of two groups.

Group 1 Participants with CP:
Participants in this group attend one test session. The total duration of this session is 30 minutes. The test session consists of measuring 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. 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 test session is to evaluate whether the hand-held device could evaluate and differentiate the passive ankle joint stiffness in subjects with CP compared to the population of healthy subjects.

Group 2 Healthy Participants:
Those in group two are allocated to a reliability study to investigate the reliability and reproducibility of the hand-held device. Each participant undergoes six test sessions with the hand-held device. Three different clinicians (raters) complete two test sessions each on the same participant. This is done for evaluation of both inter-rater and intra-rater reliability of the hand-held device.

After this, those in group two are seated in a stationary dynamometer where ten stretches of the ankle joint are automatically applied at a slow velocity. The purpose of this session is to investigate the validity of the measurements of passive joint torque obtained with the hand-he

Primary Outcome(s)

1. Intra- and inter-rater reliability of slow and fast stretches are measured using the hand-held device at baseline
2. Validity of passive ankle joint stiffness is measured comparing the hand-held device compared to the golden standard stationary dynamometer at baseline
3. Differentiation of passive ankle joint stiffness between healthy subjects and subjects with CP is measured using the hand-held device at baseline

Secondary Outcome(s)

Velocity dependent contribution to passive stiffness is assessed using the hand-held device before and during ischemic nerve block

Secondary ID(s)

N/A

Source(s) of Monetary Support

Elsass Foundation, Danske Fysioterapeuter

Ethics review

Status:
Approval date:
Contact:

Ethics Committee of Copenhagen Denmark, 06/06/2011, ref: H-4-2012-107

Results

• Results available: Yes
• Date Completed: 08/07/2014