Study Designs in Rehabilitation

Danish Hassan
Assistant Professor
RCR&AHS
Which Experimental Design to Choose?
• Six critical questions about how the study is conceptualized:
1. How many independent variables are being tested?
2. How many levels does each independent variable have, and are these
levels experimental or control conditions?
3. How many groups of subjects are being tested?
4. How will subjects be assigned to groups?
5. How often will observations of responses be made?
6. What is the temporal sequence of interventions and measurements?
Pretest-Posttest Control Group Design
Two-group pretest-posttest design
Mu lti group pretest-posttest design
Posttest-Only Control Group Design
Factorial Design
• A factorial design incorporates two or more independent
variables, with independent groups of subjects randomly
assigned to various combinations of levels of the two variables.

• Described according to their dimensions or number of factors,

so that a two-way or two-factor design has two independent
variables, a three-way or three-factor design has three
independent variables
• 3 x 3 design includes two variables, each with three levels,
• 2 x 3 x 4 design includes three variables, with two, three and four levels
• The number of groups is the product of the digits that define
the design.
• For example, 3 x 3 = 9 groups; 2 x 3 x 4 = 24 groups.

• Each cell of the matrix represents a unique combination of

levels.
Two-Way Factorial Design
• Two-way factorial design incorporates two independent
variables, A and B.
• Two independent variables are intensity of exercise (A) and
location of exercise (B), each with two levels (2 x 2).
1. One group (A1B1) will engage in moderate exercise at home.
2. Second group (A2B1) will engage in vigorous exercise at home.
3. Third group (A1B2) will engage in moderate exercise at a community
center.
4. Fourth group (A2B2) will engage in vigorous exercise at a community
center.
• This design allows us to ask three questions of the data:
(1) Is there a differential effect of moderate versus vigorous exercise?
(2) Is there a differential effect of exercising at home or a community
center?
(3) What is the interaction between intensity and location of exercise?

• Answers to the first two questions are obtained by examining the

main effect of each independent variable, with scores collapsed
across the second independent variable,
• The third question addresses the interaction effect between the
two independent variables.
Three Way Factorial Design
• Three-way factorial design, the relationship among variables can
be conceptualized in a three-dimensional format.

• We would then evaluate the simultaneous effect of intensity,

location and frequency of exercise.

• We could assign subjects to exercise 1 day or 3 days per week.

Then we would have a 2 x 2 x 2 design, with subjects assigned
to one of 8 independent groups
• We can examine the main effect for each of the three independent
variables, collapsing data across the other two.
• Examine the difference between the two intensities, regardless of the effect of
location or frequency.
• Test the difference between the two locations, regardless of intensity or frequency.
• Effect of frequency of exercise, regardless of intensity or location.

• Then we can examine three double interactions: intensity x location,

intensity x frequency, and location x frequency.

• Each double interaction represents a two-way design. Finally, we can

examine the triple interaction of intensity, location and frequency
Randomized Block Design
• When a researcher is concerned that an extraneous factor might
influence differences between groups, one way to control for this
effect is to build the variable into the design as an independent
variable.

• When an attribute variable, or blocking variable, is crossed with an

active independent variable; that is, homogeneous blocks of subjects
are randomly assigned to levels of a manipulated treatment variable.

• In the following example, we have a 2 x 3 randomized block design,

with a total of 6 groups.
Nested Design
• Example of a Nested Design
• An occupational therapist was interested in studying an intervention to
facilitate motivational behaviors in individuals with psychiatric illness
who had motivational deficits. The intervention was based on strategies
of autonomy support. Patients were randomly assigned to either an
experimental or control group, and to one of two different groups of
therapists who carried out the treatments.
One-Way Repeated Measures Design
• Example of a One-Way Repeated Measures Design
• Researchers were interested in the effect of using a cane on the
intramuscular forces on prosthetic hip implants during walking.They
studied 24 subjects with unilateral prosthetic hips under three
conditions: walking with a cane on the side contralateral to the
prosthesis, on the same side as the prosthesis, and on the contralateral
side with instructions to push with "near maximal effort." They
monitored electromyographic (EMG) activity of hip abductor muscles
and cane force under each condition. The order of testing under the
three test conditions was randomly assigned.
Crossover Design
Sequential Clinical Trials
• Special approach to the randomized clinical trial, which allows for continuous
analysis of data as they become available, instead of waiting until the end of
the experiment to compare groups.

• Results are accumulated as each subject is tested, so that the experiment can
be stopped at any point as soon as the evidence is strong enough to
determine a significant difference between treatments.

• Consequently, it is possible that a decision about treatment effectiveness can

be made earlier than in a fixed sample study, leading to a substantial
reduction in the total number of subjects needed to obtain valid statistical
outcomes and avoiding unnecessary administration of inferior treatments
• The process begins by admitting the first eligible patient into the
study. This patient is assigned to either Treatment A or B, using
the flip of a coin or some other randomization process.

• When the next eligible patient is admitted (and this may be days
or months later), he or she is assigned to the alternate treatment.

• These two patients now form a pair, the results of which can be
considered a "little experiment"; that is, we can determine for
these two people whether Treatment A or B was better.
• The whole experiment is a sequence of these "little
experiments," with each pair representing a comparison.

• The comparison between A and B is then assessed as preference

for A or B.

• Preferences are based on subjective but clearly defined criteria

for saying that one treatment is clinically more effective than the
other.
The Sequential Chart
Stopping Rules
• These boundaries represent three stopping rules:
(1) If the upper boundary is crossed, we can make a terminal decision to
recommend A;
(2) if the lower boundary is crossed, we can make a terminal decision to
recommend B;
(3) if the middle boundary is crossed (either above or below the origin),
there is no preference