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CRITICALLY APPRAISED PAPER (CAP) FOCUSED QUESTION: Will use of low-level functional electrical stimulation improve accuracy of active reaching with the upper extremity better than traditional occupational therapy treatment in a client with spasticity and limited range of motion? Ring, H., & Rosenthal, N. (2005). Controlled study of neuroprosthetic functional electrical stimulation in sub-acute post-stroke rehabilitation. Journal of Rehabilitation Medicine, 37(1), 32–36. http://dx.doi.org/10.1080/16501970410035387 CLINICAL BOTTOM LINE: This study aimed to determine whether daily functional electrical stimulation by means of a neuroprosthesis, when added to traditional outpatient therapy, increased recovery for patients in subacute poststroke programs. In particular, the researchers were interested in whether this form of self-treatment at home is a valid method of supplementing standard rehabilitation programs to improve upper limb outcomes. The specific outcomes that were measured included pain, purposeful movement, spasticity, edema, and functional movement. Researchers confirmed that with the use of a neuroprosthesis for home self-treatment, patients with chronic severe hemiparesis showed improvements in upper limb functional tasks. Statistically significant improvements in the outcomes used in this study provide evidence of a treatment intervention that may help improve functional performance of an affected extremity for tasks such as purposeful reaching. Occupational therapists may consider the use of a neuroprosthesis for functional electrical stimulation as a part of a treatment plan when looking to improve the functional use of an affected extremity poststroke. A limitation of this study is that the researchers did not investigate the continued treatment that may be required or the persistence of improvements across time. RESEARCH OBJECTIVE(S) List study objectives. To determine whether the addition of self-treatment at home with a neuroprosthesis would increase recovery in patients (as quantified by active range of motion and functional hand tests) for patients with partial hand motion resulting from chronic severe hemiparesis

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DESIGN TYPE AND LEVEL OF EVIDENCE: Level II: Quasi-experimental design. Patients were stratified according to neurological subgroup type. They were then assigned on an alternating basis to the treated and control groups. SAMPLE SELECTION The researchers did not provide specific information on how participants were recruited and selected for the study. All participants had experienced a cerebral vascular accident (CVA) and were admitted to the day hospital outpatient rehabilitation program at the Loewestein Hospital Rehabilitation Center. Inclusion Criteria Status as a patient 3–6 months after a documented single nonhemorrhagic CVA, moderate to severe hemiparesis (defined as less than full active range of motion in the involved upper limb), cognition adequate to follow multistep commands, and agreement to sign the informed consent for participation in the study Exclusion Criteria Presence of a pacemaker, uncontrolled seizure disorder, joint instability, structural impairment in the involved upper limb, severe neglect, severe aphasia, and unstable medical disorders SAMPLE CHARACTERISTICS N= (Number of participants taking part in the study) #/ (%) Male

16 (72.7%)

Ethnicity

Not specified

Disease/disability diagnosis

22

#/ (%) Female

6 (27.3%)

Side of hemiparesis Control group  

Right: 6 of 11 participants (54.5%) Left: 5 of 11 participants (45.5%)

Treated group  

Right: 4 of 11 participants (36.4%) Left: 7 of 11 participants (63.6%)

Subgroups based on level of voluntary motion:  

Type I (no active voluntary motion at the fingers and wrist): 10 of 22 participants (45.5%) Type II (partial active voluntary range of motion): 12 of 22 participants (54.5%) 2

INTERVENTION(S) AND CONTROL GROUPS Add groups if necessary Group 1: Intervention group Brief description of the intervention

All patients received similar rehabilitation services that were not adjusted or modified on the basis of group assignment. Regular physical and occupational therapy treatment included neuromuscular reeducation with the Bobath techniques and functional treatment to improve performance of activities of daily living (ADLs). This group was fitted with the Handmaster upper limb neuroprosthesis and was instructed on a protocol for daily use of the neuroprosthesis in their home. Participants used two therapeutic stimulation modes: intermittent finger extension, and alternating finger flexion and extension.

How many participants in the group?

11

Where did the intervention take place?

Use of the Handmaster took place in the participant’s home. Standard rehabilitation services took place at the day hospital outpatient rehabilitation program.

Who Delivered?

The use of the Handmaster upper limb neuroprosthesis was selfadministered after initial fitting. The traditional rehabilitation services were carried out by physical and occupational therapists.

How often?

Participants attended 3 days per week of outpatient rehab services and received at least 3 hr of services per visit. The neuroprosthetic program started with daily system use at 10 min twice a day and progressed up to 50 min three times a day over the first 3 weeks. Patients’ use of the neuroprosthesis then remained at that level through the remainder of the 6-week study.

For how long?

All patients were reevaluated 6 weeks after beginning the study.

Group 2: Control group Brief description of the intervention

All patients received similar rehabilitation services that were not adjusted or modified on the basis of group assignment. Regular physical and occupational therapy treatment included neuromuscular reeducation with the Bobath techniques and functional treatment to improve ADL performance. The control group did not seem to receive a home program issued by the researchers that was equal to the total amount of therapy received by the intervention group outside of traditional rehab.

How many participants in the group?

11

Where did the

Rehabilitation services took place at the day hospital outpatient 3

intervention take place?

rehabilitation program.

Who Delivered?

Traditional rehabilitation services were carried out by physical and occupational therapists.

How often?

Participants attended 3 days per week of outpatient rehab services and received at least 3 hr of services per visit.

For how long?

All patients were reevaluated 6 weeks after beginning the study.

Intervention Biases: Check yes, no, or NR and explain, if needed. Contamination: YES ☐ NO ☒ NR ☐ Co-intervention: YES ☒ NO ☐ NR ☐

Comment: Participants in the control group were not fitted with the neuroprosthesis, which eliminates the chance of contamination bias.

Comment: Although there was no direct evidence of cointervention bias, the researchers acknowledged that participants might have been receiving additional treatments for communication, psychological intervention, and cognitive deficits. These services were provided as needed as a part of their rehabilitation program. Not all participants received these services, and the dosing of such services was not reported. The researchers reported that participants also received varying amounts of therapy and that only the minimum number of hours received was known (at least 3 hr of services each of the 3 days a week they attended).

Timing: YES ☐ NO ☒ NR ☐

Comment: There was no risk for timing bias as a result of maturation effects. The duration of the study seemed sufficient to measure improvements in the treatment group.

Site: YES ☐ NO ☒ NR ☐

Comment: The traditional rehabilitation treatment occurred in the same location for both groups, and all experimental treatment occurred in the participants’ home.

Use of different therapists to provide intervention: Comment: The researchers did not specify whether the same therapists YES ☒ treated the participants during traditional rehabilitation services in the NO ☐ outpatient hospital setting. They also did not state whether more than one NR ☐ person instructed participants on use of the neuroprosthesis, which allowed for bias. The researchers did not provide information on fidelity or training of therapists. 4

MEASURES AND OUTCOMES Measure 1: Name/type of Goniometry measure used: What outcome was Active forward flexion and abduction range of motion at the shoulder measured? were tested. Active flexion and extension range of motion at the elbow and wrist were both tested. The researchers measured both finger flexion and extension during active movement by recording the distance from the fingertips to the mid-palmar crease. Is the measure YES ☐ NO ☐ NR ☒ reliable? Is the measure YES ☐ NO ☐ NR ☒ valid? When is the At baseline and at the final evaluation after the 6-week study measure used? Measure 2: Name/type of measure used: What outcome was measured? Is the measure reliable? Is the measure valid? When is the measure used? Measure 3: Name/type of measure used: What outcome was measured? Is the measure reliable? Is the measure valid? When is the measure used? Measure 4: Name/type of measure used: What outcome was measured?

Modified Ashworth Scale Muscle tone and grade spasticity at the shoulder, elbow, wrist, and fingers YES ☐

NO ☐

NR ☒

YES ☐

NO ☐

NR ☒

At baseline and at the final evaluation after the 6-week study

Blocks and Box Test Manual dexterity YES ☐

NO ☐

NR ☒

YES ☐

NO ☐

NR ☒

At baseline and at the final evaluation after the 6-week study

Jebsen–Taylor Hand Function Test Unimanual hand function required for ADLs. The researchers chose to use the subtests for simulated eating, lifting large light objects, and lifting 5

Is the measure reliable? Is the measure valid? When is the measure used?

large heavy objects. These tests were all chosen because they test functional grasp and release in standardized time trials. They also provide quantifiable information regarding ADLs (self-feeding). YES ☐ NO ☐ NR ☒ YES ☐

NO ☐

NR ☒

At baseline and at the final evaluation after the 6-week study

Measurement Biases Were the evaluators blind to treatment status? Check yes, no, or NR, and if no, explain. Comment: The assessor was blinded. YES ☒ NO ☐ NR ☐ Recall or memory bias. Check yes, no, or NR, and if yes, explain. Comment: The researchers did not formally address recall or memory bias. A YES ☐ questionnaire or survey was not used, so it is not likely that there was recall NO ☒ or memory bias. NR ☐

Others (list and explain):

RESULTS List key findings based on study objectives Include statistical significance where appropriate (p