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Cervical Spinal Cord InjuryNCT01963026

Linking Brain to Behaviour Research in SCI

A study testing ToCUEST featuring a 'variable practice' approach. and ToCUEST featuring a 'constant practice' approach. in people with Cervical Spinal Cord Injury, run by Adelante, Centre of Expertise in Rehabilitation and Audiology at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Introduction In recent years, client-centred and task-oriented training have emerged as important methods in rehabilitation including the rehabilitation of persons with spinal cord injury (SCI). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Cervical Spinal Cord Injury
What is being tested?
ToCUEST featuring a 'variable practice' approach. and ToCUEST featuring a 'constant practice' approach.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteNetherlands
Study dates
Nov 2013to Jul 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • in)complete C-SCI at level C3-T1; age between 18 and 70 years; patients are able to sit in a wheelchair for at least for 2 consecutive hours; presence of problems with specific arm-hand skilled performance

Who cannot join

  • opinion of an independent rehabilitation physician that additional neurological, orthopaedic or rheumatologic diseases strongly interfere with Activities of Daily Living (ADL) functioning and arm hand skilled performance; inability to perform arm hand skilled performance measurements

Trial locations and contacts

1 site in 1 country.

Netherlands1 site
  • Adelante Rehabilitation Centre

    Hoensbroek, Limburg, 6432CC

Other trials in Netherlands

About this study

Official title: Plasticity, Motor Learning and Functional Recovery Induced by Client-centred Task-oriented Training of the Upper Extremity in Tetraplegia

Introduction In recent years, client-centred and task-oriented training have emerged as important methods in rehabilitation including the rehabilitation of persons with spinal cord injury (SCI). The task-oriented intervention focuses on resolving, reducing and preventing impairment, developing effective task-specific strategies and adapting functional goal-oriented strategies to changing environmental conditions. Currently, task-specific training is mainly achieved by constant practice (i.e. repeating the task without variation) and is reported to improve performance of the trained task, but to have a negative impact on untrained tasks. Practice variability, however, is reported being advantageous to transfer training results into daily live. This paradox poses challenges in clinical practice, where task-specific training is essential to deliver client-centred training in order to focus on the patients' specific individual goals, but practice variability is important to be able to transfer the learned task into daily practice. Questions regarding the effective elements within rehabilitative interventions and the exact mechanisms behind the cerebral changes they may induce, remain. These questions require further research, for which ultra-high field fMRI techniques will be used. Furthermore, compensation of muscle function loss (i.e. the development of new muscle synergies) plays an important role in the improvement of skill performance in cervical SCI. Surface EMG allows to study the changes in muscle coordination, parallel to the changes at cerebral level.

Aims This study aims to

Read more
  1. investigate which basic neural mechanisms of motor learning underlie functional recovery of arm hand skilled performance during client-centred task-oriented training of the upper limb in patients with cervical spinal cord injury and
  2. investigate the contribution of 'practice variability' in contrast to 'constant practice' on arm-hand skilled performance, motor control and neural changes.

Study design This study features a multiple single-case experimental design (A-B-C design) with baseline (phase A) (6 weeks), intervention B (phase B) (3 weeks) and intervention C (phase C) (3 weeks). Intervention B will contain the 'practice variability' component. Intervention C will feature the 'constant practice' component. The order of phase B and C will be randomly assigned to participants. Four measurements during baseline and after each intervention phase (B and C) will be performed, thus producing a time series, per measure, for each patient. Also, meta-analyses on the pooled single-case data will be performed.

Setting/population Six patients with a cervical SCI (complete and incomplete) will be recruited from the Spinal cord unit of Adelante Rehabilitation Centre in the (sub)acute phase.

Intervention After therapy as usual (intervention A), the Task-oriented Client-centred Upper Extremity Skill Training (ToCUEST) module (Spooren et al., 2011) will be provided. In this program individual goals will be extracted using the Canadian Occupational Performance Measure(COPM) and the training program is based on a task-analysis and uses principles of training physiology and motor learning. Intervention B will consist of the ToCUEST program, including the component 'practice variability' (ToCUEST variability). Intervention C will consist of a modified ToCUEST program in which the component 'practice variability' will be replaced by 'constant practice' (ToCUEST constant) in order to evaluate the contribution of these components. Intervention A' will be therapy as usual.

Measurements Measurements will be taken at the level of activities (arm hand skilled performance, i.e. Van Lieshout Test, Spinal Cord Independence Measure, Goal Attainment Scale) and body function (Upper Extremity Motor Score, Graded Redefined Assessment of Strength Sensibility and Prehension Test, Surface EMG), and at cerebral level, i.e. neural activity changes (by means of ultra-high field fMRI).

The fMRI measurements will be taken before and after each intervention B and C in 4 patients (2 with complete and 2 with incomplete lesion).

Data-analyses Baseline data stability and any baseline trends regarding the outcome measures at body function level and activity level will be assessed. To control for, e.g., spontaneous recovery effects, baseline data (phase A) will be used in a computer-based detrending model. For the meta-analyses, mean data per outcome measure, per phase, per subject will be pooled and subsequently analysed using non-parametric statistics, i.e. Friedman analyses and Wilcoxon tests.

Being tested
ToCUEST featuring a 'variable practice' approach., ToCUEST featuring a 'constant practice' approach.
Keywords
spinal cord injury, upper extremity, skill performance, motor learning
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ToCUEST featuring a 'variable practice' approach.Other

    Intervention Variable practice: The ToCUEST (Task-Oriented Client-centred Upper Extremity Skill Training) module [17] will be given to the participants, in which individual goals will be extracted using the COPM (Canadian Occupational Performance Measure). The training program will start with a task analysis and is based on principles of training physiology and motor learning, including variability practice, random practice, distribution based practice, feedback, whole learning. A detailed description of the ToCUEST module is given in Spooren et al. [17]. Intervention B will be called 'ToCUEST variability' in the present project.

  • ToCUEST featuring a 'constant practice' approach.Other

    Intervention Constant practice: In order to evaluate the contribution of the component 'variability practice' in contrast with 'constant practice' the participants will be offered the modified ToCUEST ('ToCUEST constant') module in which the component 'variability practice' is replaced by 'constant practice'.

Study groups in NCT01963026
Study groupRoleWhat they receive
ToCUEST (constant or variable practice)ExperimentalAfter therapy as usual (intervention A), the Task-oriented Client-centred Upper Extremity Skill Training (ToCUEST) module (Spooren et al., 2011) will be given. In this program individual goals will be extracted using the COPM (Canadian Occupational Performance Measure) and the training program is based on a task-analysis and uses principles of training physiology and motor learning. Intervention B will consist of the ToCUEST program, including the component 'practice variability' (ToCUEST variability). Intervention C will consist of a modified ToCUEST program in which the component 'practice variability' will be replaced by 'constant practice' (ToCUEST constant) in order to evaluate the contribution of these components. Intervention A' will be therapy as usual.
Receives: Other: ToCUEST featuring a 'variable practice' approach.; Other: ToCUEST featuring a 'constant practice' approach.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline VanLieshout hand function test for Tetraplegia (Short Form) (VLT-SF) at 3 weeks

    VLT-SF: assesses the actual performance of arm hand skills at the level of basic activities. The criterion validity, reliability, the internal consistency and the responsiveness of the VLT-SF were found to be good [Spooren et al, Spinal Cord 2006; Post et al. Spinal Cord 2006]. In the present study, the Rasch modified short form VLT will be used measuring both hands [Spooren et al, Spinal Cord 2013a,b].

    Measured: Pre (4x baseline) & post intervention1 (3 weeks (4x))

  2. Change from baseline VanLieshout hand function test for Tetraplegia (Short Form) (VLT-SF) at 6 weeks

    VLT-SF: assesses the actual performance of arm hand skills at the level of basic activities. The criterion validity, reliability, the internal consistency and the responsiveness of the VLT-SF were found to be good [Spooren et al, Spinal Cord 2006; Post et al. Spinal Cord 2006]. In the present study, the Rasch modified short form VLT will be used measuring both hands [Spooren et al, Spinal Cord 2013a,b].

    Measured: Pre (4x baseline) & post intervention2 (6 weeks (4x))

  3. Changes from baseline surface electromyography (EMG) activity patterns at 3 weeks

    During task performance (specific task and standardized arm hand tasks) muscle activity patterns will be recorded of main shoulder, arm and hand muscles using a 16 channel Trigno surface electromyography system (Delsys Inc, Boston, MA).

    Measured: Pre (4x baseline) & post intervention1 (3 weeks (4x))

  4. Changes from baseline surface electromyography (EMG) activity patterns at 6 weeks

    During task performance (specific task and standardized arm hand tasks) muscle activity patterns will be recorded of main shoulder, arm and hand muscles using a 16 channel Trigno surface electromyography system (Delsys Inc, Boston, MA).

    Measured: Pre (4x baseline) & post intervention2 (6 weeks (4x))

Secondary outcomes (12)
  1. Change from baseline Spinal Cord Independence Measure (SCIM (self-care)) at 3 weeks

    SCIM (self-care): the Spinal Cord Independence Measure is an instrument that assesses functional recovery in the total SCI population. In the present study, the SCIM self-care will be used , which is reported as reflecting the level of arm and hand functioning

    Measured: Pre (4x baseline) & post intervention1 (3 weeks (4x))

  2. Change from baseline Spinal Cord Independence Measure (SCIM (self-care)) at 6 weeks

    SCIM (self-care): the Spinal Cord Independence Measure is an instrument that assesses functional recovery in the total SCI population. In the present study, the SCIM self-care will be used , which is reported as reflecting the level of arm and hand functioning

    Measured: Pre (4x baseline) & post intervention2 (6 weeks (4x))

  3. Changes from baseline Goal Attainment Scaling (GAS) at 3 weeks

    Goal Attainment Scale is used to objectively measure the effect of therapy on individual treatment goals and has shown to be feasible, reliable, valid and responsive to change [31]. Goals are defined in a range from -2 (level of performance before the start of the training), 0 (expected performance after finishing the training) to +2 (much more than expected scores after finishing the training) [32]. To have an additional measure of transfer effects, the + 2 score of each goals will be defined with regard to generalized tasks related to the specific individual chosen task.

    Measured: Pre (baseline) & post intervention1 (3 weeks)

  4. Changes from baseline Goal Attainment Scaling (GAS) at 6 weeks

    Goal Attainment Scale is used to objectively measure the effect of therapy on individual treatment goals and has shown to be feasible, reliable, valid and responsive to change [31]. Goals are defined in a range from -2 (level of performance before the start of the training), 0 (expected performance after finishing the training) to +2 (much more than expected scores after finishing the training) [32]. To have an additional measure of transfer effects, the + 2 score of each goals will be defined with regard to generalized tasks related to the specific individual chosen task.

    Measured: Pre (baseline) & post intervention2 (6 weeks)

  5. Changes from baseline Upper Extremity Motor Score (UEMS) at 3 weeks

    Upper Extremity Motor Score based on the ASIA (American International Standards for Neurological and Functional Classification of Spinal Cord Injury) including elbow flexion, wrist extension, elbow extension, finger flexors and finger abductor

    Measured: Pre (4x baseline) & post intervention1 (3 weeks (4x))

  6. Changes from baseline Upper Extremity Motor Score (UEMS) at 6 weeks

    Upper Extremity Motor Score based on the ASIA (American International Standards for Neurological and Functional Classification of Spinal Cord Injury) including elbow flexion, wrist extension, elbow extension, finger flexors and finger abductor

    Measured: Pre (4x baseline) & post intervention2 (6 weeks (4x))

  7. Changes from baseline functional Magnetic Resonance Imaging (fMRI) at 3 weeks

    Neuroimaging data will be collected at Maastricht Brain Imaging Centre (M-BIC) in Maastricht (The Netherlands) using a Siemens whole-body MRI scanner. Patients undergo 3 fMRI sessions during which high-resolution anatomical images (T1-weighted) will be collected as well as high-resolution functional images. The functional stimulus task is performed using a blocked design. During the active periods the patient will perform a repeated arm-hand task.

    Measured: Pre (baseline) & post intervention1 (3 weeks)

  8. Changes from baseline functional Magnetic Resonance Imaging (fMRI) at 6 weeks

    Neuroimaging data will be collected at Maastricht Brain Imaging Centre (M-BIC) in Maastricht (The Netherlands) using a Siemens whole-body MRI scanner. Patients undergo 3 fMRI sessions during which high-resolution anatomical images (T1-weighted) will be collected as well as high-resolution functional images. The functional stimulus task is performed using a blocked design. During the active periods the patient will perform a repeated arm-hand task.

    Measured: Pre (baseline) & post intervention2 (6 weeks)

  9. Changes from baseline Hand-held dynamometry at 3 weeks

    Muscle strength will be tested for muscles with strength of at least 3 out of 5 on the manual muscle test.

    Measured: Pre (4x baseline) & post intervention1 (3 weeks (4x))

  10. Changes from baseline Hand-held dynamometry at 6 weeks

    Muscle strength will be tested for muscles with strength of at least 3 out of 5 on the manual muscle test.

    Measured: Pre (4x baseline) & post intervention2 (6 weeks (4x))

  11. Changes from baseline Grades Redefined Assessment of Strength Sensibility and Prehension (GRASSP) at 3 weeks

    GRASSP (Grades redefined assessment of strength sensibility and Prehension): clinical impairment measure that incorporates 3 domains: sensibility, strength and prehension and has been proven to be valid and reliable.

    Measured: Pre (4x baseline) & post intervention1 (3 weeks (4x))

  12. Changes from baseline Grades Redefined Assessment of Strength Sensibility and Prehension (GRASSP) at 6 weeks

    GRASSP (Grades redefined assessment of strength sensibility and Prehension): clinical impairment measure that incorporates 3 domains: sensibility, strength and prehension and has been proven to be valid and reliable.

    Measured: Pre (4x baseline) & post intervention2 (6 weeks (4x))

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionJun 2015
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01963026
Sponsor's protocol ID
NL44697.068.13
Status last verified
Dec 2015
First submitted
1 Oct 2013
Last updated
29 Dec 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing ToCUEST featuring a 'variable practice' approach. and ToCUEST featuring a 'constant practice' approach. in people with Cervical Spinal Cord Injury, run by Adelante, Centre of Expertise in Rehabilitation and Audiology at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline VanLieshout hand function test for Tetraplegia (Short Form) (VLT-SF) at 3 weeks (time frame: Pre (4x baseline) & post intervention1 (3 weeks (4x))). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2015.

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