A method for standardizing procedures in rehabilitation: use in the extremity constraint induced therapy evaluation multisite randomized controlled trial

Arch Phys Med Rehabil. 2009 Apr;90(4):663-8. doi: 10.1016/j.apmr.2008.09.576.


Objective: An enduring problem in the field of rehabilitation has been the lack of standardization in the protocols of treatments and tests. To develop a process evaluation method to standardize the administration of rehabilitation procedures used in the Extremity Constraint Induced Therapy Evaluation (EXCITE) Trial, a randomized controlled trial of upper-extremity constraint-induced therapy implemented across 7 sites.

Design: Process evaluation.

Setting: Research laboratory.

Participants: Convenience sample or research personnel.

Interventions: Not applicable.

Main outcome measures: Checklist scoring sheets were developed to rate videotapes using systematic application of prescribed steps for each of 5 procedures across 3 time periods. Time periods were immediately after training, and 1 and 2 years later. A performance score of at least 90% was required before individual research personnel were allowed to participate in the trial.

Results: Overall performance scores ranged from 85.8% to 95% of performance items correctly executed. There was a significant improvement in standard performance of procedures between the first time period (immediately after training) and each of the subsequent time periods for all but 1 procedure. The scoring of standardized performance when carried out with routine participant testing and training did not differ significantly from scoring from videotaped sessions submitted for standardization rating for 2 of the procedures, suggesting adequate validity of scoring from videotape.

Conclusions: The present method was successful in assessing protocol fidelity for the EXCITE research personnel and represents 1 means of addressing the longstanding problem in rehabilitation of the lack of standardization in administering different treatments and tests.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Analysis of Variance
  • Arm / physiopathology*
  • Clinical Protocols / standards
  • Exercise Therapy / standards*
  • Humans
  • Occupational Therapy / standards
  • Physical Therapy Specialty / standards
  • Process Assessment, Health Care*
  • Research Design
  • Stroke Rehabilitation*
  • Videotape Recording