Confounders in Rehabilitation Trials of Task-Oriented Training: Lessons From the Designs of the EXCITE and SCILT Multicenter Trials

Neurorehabil Neural Repair, 2007 · DOI: 10.1177/1545968306297329 · Published: January 1, 2007

Neurorehabilitation Research Methodology & Design

Simple Explanation

Multicenter randomized clinical trials (MRCT) for novel task- oriented interventions improved walking after incomplete spinal cord injury (SCI) and increased upper extremity function in patients with hemiparetic stroke. These trials gathered enough subjects who met entry criteria to demonstrate that the intervention could be provided by many therapists in a similar fashion to produce similar results. Future trials, at least in the United States, are likely to draw upon previously published designs, as well as explore ways to improve upon them.

Study Duration

EXCITE: 1 year; SCILT: 12 weeks intervention, 12 months follow-up

Participants

EXCITE: 222 stroke patients; SCILT: 155 incomplete SCI patients

Evidence Level

Level 1: Multicenter Randomized Clinical Trials

Key Findings

1
In EXCITE, the CIMT group increased the speed at which it completed a battery of standardized tasks with the affected hand compared to the control group that did not receive any therapy.
2
In SCILT, the BWSTT and control groups had equal outcomes at the end of therapy and at 6 and 12 months for level of walking independence, walking speed and distance, need for assistive devices, and leg strength.
3
These trials added weight to the evidence of the few available RCTs that progressive, task-specific training of considerable intensity for patients who have enough spared motor control can significantly improve outcomes relevant to the focus of what was practiced.

Research Summary

Two multicenter randomized clinical trials (MRCT), the Extremity Constraint Induced Therapy Evaluation (EXCITE) to improve upper extremity function after stroke and the Spinal Cord Injury Locomotor Trial (SCILT) to enable functional walking after incomplete spinal cord injury, demonstrate that complex, task-oriented physical therapies can be studied using a scientific methodology during inpatient or outpatient rehabilitation. MRCT designs will continue to improve through attention to the limitations of preclinical animal models that offer a conceptual basis for the treatment from enrichment strategies at every phase of trial development from more vigorous dose-response studies using adaptive methods by capturing interim measures of behavior and functional neurophysiologic adaptations during the treatment phase by aiming for a clinically meaningful control intervention and by including ratio or interval outcome measures when feasible that capture a target of the intervention in relation to gains in daily functioning and quality of life. Careful investigators will drive within the speed limit to destinations that must be reached, including the roads to dose-response curves and worthy interim and primary outcome measures, before setting out for the golden goal posts of the MRCT.

Practical Implications

Improved Trial Design

Future MRCT designs should incorporate lessons learned from EXCITE and SCILT, including rigorous dose-response studies and clinically meaningful control interventions.

Careful Patient Selection

Inclusion and exclusion criteria should be carefully considered to identify patients most likely to benefit from the intervention, potentially using biomarkers.

Focus on Task-Specific Training

Task-oriented training with adequate intensity can improve outcomes relevant to the focus of what was practiced, suggesting the importance of specificity in rehabilitation interventions.

Study Limitations

1
Animal models are limited to simple behaviors acquired by reinforcers such as a sweet drink or food pellet.
2
The EXCITE intervention was designed for a very specific and rarified level of impairment and was only better than no treatment.
3
A possible problem in SCILT and EXCITE was that the primary outcome measures for walking and functional use of the affected hand were closely aligned to what the active treatment group practiced during formal and informal therapy.

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