Linking Brain to Behaviour Research in SCI

NCT01963026 | Completed

• 1 other identifier: NL44697.068.13
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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). 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

1. 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. 2.investigate the contribution of 'practice variability' in contrast to 'constant practice' on arm-hand skilled performance, motor control and neural changes.

Conditions

Cervical Spinal Cord Injury

Keywords

spinal cord injury; upper extremity; skill performance; motor learning

Outcome Measures

Primary Outcomes (4)

• 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 \[Spooren et al, Spinal Cord 2013a,b\].

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

• 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 \[Spooren et al, Spinal Cord 2013a,b\].

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

• 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).

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

• 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).

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

Secondary Outcomes (12)

• Change from baseline Spinal Cord Independence Measure (SCIM (self-care)) at 3 weeks

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

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

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

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

  Pre (baseline) & post intervention1 (3 weeks)

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

  Pre (baseline) & post intervention2 (6 weeks)

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

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

Study Arms (1)

ToCUEST (constant or variable practice)

EXPERIMENTAL

After 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.

Other: ToCUEST featuring a 'variable practice' approach.; Other: ToCUEST featuring a 'constant practice' approach.

Interventions

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 (constant or variable practice)

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'.

ToCUEST (constant or variable practice)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adelante, Centre of Expertise in Rehabilitation and Audiology: lead
• Adelante rehabilitation Centre: collaborator
• Maastricht University: collaborator

Study Sites (1)

Adelante Rehabilitation Centre

Hoensbroek, Limburg, 6432CC, Netherlands

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Henk AM Seelen, Dr.

  Adelante Centre of Expertise in Rehabilitation and Audiology (NL)

  PRINCIPAL INVESTIGATOR

• Annemie IF Spooren, Dr.

  University College PXL (Belgium)

  PRINCIPAL INVESTIGATOR

• Amanda Kaas, Dr.

  Maastricht University (NL)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Co-ordinator

Study Record Dates

• First Submitted: October 1, 2013
• First Posted: October 16, 2013
• Study Start: November 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: December 29, 2015

Record last verified: 2015-12

Locations

NL (1)