Stroke Rehab Studies Should Consider Patient-Selected Goals

Daniel M. Keller, PhD

December 10, 2012

Brasilia, Brazil — Even when objective measures of upper-limb rehabilitation after a stroke failed to show benefit in a recent treatment trial, patients found satisfaction in their progress if that progress was assessed on the basis of attainment of patient-specified goals.

Lisa Shaw, MD, senior research associate in the Institute for Ageing and Health at Newcastle University in Newcastle upon Tyne, United Kingdom, pointed out that one third of patient-driven goals were bimanual, assessing the function of both hands, which may have accounted for better outcomes that standard measures may have missed.

In a test of the use of botulinum toxin-A (BT) along with a standard upper-limb therapy program, researchers found that on objective measures of arm function after a stroke, neither therapy improved function after 1 month. However, patients reported they were equally satisfied with either therapy when satisfaction was based on attainment of goals they had chosen themselves.

Dr. Shaw presented the results here at the 8th World Stroke Congress (WSC).

What Matters to Patients

The original Botulinum Toxin for Upper Limb after Stroke (BoTULS) trial compared upper-limb therapy alone with therapy plus BT. It found that using BT improved muscle tone at 1 month and longer-term, basic arm function tasks, arm strength, and pain. But it failed to improve arm function overall. BT, which blocks neuromuscular transmission and thereby induces a prolonged but temporary paresis, has increasingly been used to reduce spasticity.

The investigators then asked which therapy goals patients choose and how attainment of those goals compares with outcomes on a standard arm function test. They designed a randomized, controlled clinical trial with blinded observers to look at arm function as measured by the Action Research Arm Test (ARAT), consisting of grasp, grip, pinch, and gross movement assessments, vs patient-centered goal attainment, as assessed by the Canadian Occupational Performance Measure (COPM) involving performance and satisfaction.

Participants were adults with upper-limb spasticity and reduced function at least 1 month after stroke. In both groups, the average age was 68 years, 65% to 71% of patients were men, and about 82% of participants had had a thrombotic stroke. The median time between stroke and trial randomization was 280 days for the control group and 324 days for the BT intervention group. At baseline, both groups had median ARAT scores of 3 on a scale of 0 to 57. Median COPM scores on a scale of 1 to 10 were 2.0 for both performance and satisfaction in the intervention group and 1.7 and 1.6, respectively, in the control group.

The interventions were a 1-month upper-limb therapy program for 1 hour twice weekly with (n =170) or without (n = 162) BT, at which time outcomes were assessed. BT was injected into muscles of the hand, wrist, elbow, or shoulder according to the individual patterns of spasticity.

Treatments focused on 4 set goals and 1 optional goal within the COPM. For ARAT, the focus was on stretching, passive, and active assisted upper-limb movement; hygiene; positioning; and intensive task-oriented practice.

The most commonly selected goals — by about 90% of each group — were dressing, washing, and eating and drinking. Participants chose goals of self-care (66%); productivity, such as working in the kitchen, managing the household, playing, going to school, or writing (19%); and leisure activities (16%). One third of the goals involved bimanual tasks.

Patient Satisfaction Up Despite Lack of Function

After 1 month, there were no objective differences in the degree of improvement between the BT and control groups. No change from baseline (change score, 0) on the ARAT occurred in either group (P = .427). There was a median 2.3-point change from baseline in both the BT and control groups on the COPM performance component (P = .535) and a 2.3-point and 2.4-point change, respectively, on the COPM satisfaction component (P = .342).

Despite the finding that BT did not enhance goal attainment or arm function compared with standard upper-limb therapy alone, Dr. Shaw said both the BT and control groups had clinically relevant improvements of greater than 2 points on the COPM. ARAT measures are largely unimanual, whereas many COPM measures involve both of the hands and arms. She said the study highlights the importance of including patient-specified goals in rehabilitation studies.

Session moderator Werner Hacke, MD, PhD, MPsych, professor and chairman of the Department of Neurology at the University of Heidelberg, Germany, concurred, saying he was not surprised that the patients felt that they had benefited despite a lack of objective improvement in arm function.

"It is about caring about the patient, and I believe it doesn't matter what you do," he commented to Medscape Medical News. "If you care and you have a positive psychological impact on the patients, they will benefit, and they feel better. And then you measure it, and they have not improved, but their overall feeling is better — and this is what is probably the most important thing about early rehabilitation — spending time with the patient, independent of what you do."

He noted that there is no proof that one or another physical therapy approach is better than another. If "caring" is the intervention that makes the patient feel better, Dr. Hacke said this factor is even stronger in a clinical trial "because there are more people involved... [and] they have a very strong intention to help, and that translates."

He found it surprising that arm function was not at all measurably improved with BT to reduce spasticity because a reduction in spasticity may make it possible to grasp a cup, for example. "I would have expected some signal, a trend. And that is disturbing that there is not even a trend," he said.

There was no commercial funding for the study. Dr. Shaw has disclosed no relevant financial relationships. Dr. Hacke did not participate in the trial and has disclosed no relevant financial relationships.

8th World Stroke Congress (WSC). Abstract 820. Presented October 11, 2012.