Background and Objective: Following stroke, it is common to exhibit motor impairments and decreased use of the upper limb. The objective of the present study was to evaluate forced use on arm function during the subacute phase after stroke.

Design: A comparison of standard rehabilitation only and standard rehabilitation together with a restraining sling was made through a randomized, nonblinded, clinical pilot trial with assessments before intervention, after intervention, and at 1- and 3-month follow-ups.

Setting: The present study took place at the departments of rehabilitation medicine, geriatrics, and neurology at a university hospital.

Participants: A convenience sample of 30 people 1 to 6 months (mean, 2.4 mo) after stroke was randomized into 2 groups (forced-use group and standard training group) of 15 people each. Twenty-six participants completed the 3-month follow-up.

Intervention: All participants received their standard rehabilitation program with training 5 days per week for 2 weeks as inpatients or outpatients. The forced-use group also wore a restraining sling on the nonparetic arm with a target of 6 hours per day.

Measurements: The Fugl-Meyer (FM) test, the Action Research Arm Test, the Motor Assessment Scale (MAS) (sum of scores for the upper limb), a 16-hole peg test (16HPT), a grip strength ratio (paretic hand to nonparetic hand), and the Modified Ashworth Scale were used to obtain measurements.

Results: The changes in the forced-use group did not differ from the changes in the standard training group for any of the outcome measures. Both groups improved over time, with statistically significant changes in the FM test (mean score changed from 52 to 57), MAS (mean score changed from 10.1 to 12.4), 16HPT (mean time changed from >92 seconds to 60 seconds), and grip strength ratio (mean changed from 0.40 to 0.55).

Limitations: The limitations of this pilot study include an extended study time, a nonblinded assessor, a lack of control of treatment content, and a small sample size.

Conclusions: The results of the present pilot study did not support forced use as a reinforcement of standard rehabilitation in the subacute phase after stroke. Forced use did not generate greater improvements with regard to motor impairment and capacity than standard rehabilitation alone. The findings of this effectiveness study will be used to help design future clinical trials with the aim of revealing a definitive conclusion regarding the clinical implementation of forced use for upper-limb rehabilitation.

Stroke is the leading cause of disability in many countries.1 Because motor deficits and decreased use of the upper limb are frequent problems after stroke, it is important to develop cost-effective rehabilitation approaches designed to address these problems.

Many patients with arm paresis after stroke initially activate mostly their nonparetic side to be as independent as possible.2,3 There is usually some restoration of motor capacity in the paretic upper limb, but the patient often fails to complete daily tasks with that limb.2,3 This behavioral development of not using the recovering upper limb is known as “learned nonuse.”3 Both the theory of learned nonuse and the notion of bringing the paretic side into more use by restraining the nonparetic side with a sling were introduced in primate research. Restraint alone induced the use of the forelimb in these experiments when restriction was used for a week or more.2

On the basis of these primate experiments, pioneer studies in patients with stroke involved the application of a restraining sling, termed “forced use,” without any training.4,5 Both studies indicated a positive effect in the chronic stage after stroke for upper-limb motor function. In an initial randomized controlled trial (RCT), forced use was combined with training for 2 weeks in 4 patients at least 1 year after stroke. Promising results for motor function and the use of the upper limb were seen immediately after the intervention and at a 2-year follow-up relative to the results seen for 5 patients in a control group.3 The short-term effect was explained by the neurophysiologic effects of unmasking, that is, bringing latent neural pathways into use.3

The concept of overcoming learned nonuse was further developed and described6 as a combination of immobilization of the unaffected arm and intensive training of the affected arm. The classic design of constraint-induced movement therapy (CIMT) involves massed practice (intense, concentrated, repetitive exercises with increasing speed or difficulty following improvements of performance) 6 hours per day for 2 weeks and the use of a restraining device for 90% of waking time.6 Further promising results were seen in the chronic stage after stroke, mostly in studies in which training was conducted in research laboratories.7

From a clinical perspective, training patients individually for 6 hours per day is rarely feasible. Several attempts at modifying CIMT have been made since concerns were raised regarding patient and therapist devotion to CIMT8 and available resources in clinical settings.9 There also is an ongoing discussion regarding the actual effect of CIMT and the importance of the various components.2,1014 The restraining aspect initially was presented as the essential factor,3,15 but intense training frequently has been referred to as the crucial treatment factor.2,7 The most recent descriptions of the concept of CIMT emphasize not only the components of immobilization and intense training but also a behavioral approach to facilitating the transfer of motor behavior during exercise to daily use in the home environment.1618 This shift of emphasis in CIMT places the focus on learning strategies to accomplish transfer to daily use by means of an agreement regarding behavior and strategies. Identification of the critical elements of the CIMT paradigm has been and continues to be elusive.

Because learned nonuse was proposed to develop in the acute and subacute phases after stroke, questions were posed about whether overcoming or even preventing its occurrence would be more efficient in early rehabilitation because of greater brain plasticity.4,5,19 The present RCT was based on knowledge from initial studies in this area.35 We transferred the idea of overcoming learned nonuse by applying forced use in our context of clinical rehabilitation. The present study was intended to test whether providing only the constraint component of CIMT could reinforce standard rehabilitation during the subacute stage. Thus, at the start of our study, there were no reports on forced use or CIMT during the subacute stage after stroke.

Testing of health care interventions is frequently classified as efficacy, effectiveness, and efficiency studies.20 Seemingly similar in meaning, these terms express distinctly different concepts. Efficacy represents evaluation of an effect during ideal circumstances; effectiveness represents whether an intervention works in usual circumstances, such as routine clinical care; and efficiency represents effect in relation to cost. The present study tested effectiveness because the environment was standard rehabilitation in clinical health care.

The purpose of this study was to evaluate the effectiveness of 2 weeks of forced use on arm function after stroke. The specific aim was to investigate any differences in changes in motor impairment and capacity between a group of patients wearing a restraining sling in addition to receiving rehabilitation training and a group of patients receiving rehabilitation training only.