Susan L. Garber

Robot-Assisted Upper-Limb Therapy in Acute Rehabilitation Setting Following Stroke: Department of Veterans Affairs Multisite Clinical Trial

This randomized, controlled, multisite Department of Veterans Affairs clinical trial assessed robot-assisted (RA) upper-limb therapy with the Mirror Image Movement Enabler (MIME) in the acute stroke rehabilitation setting. Hemiparetic subjects (n = 54) received RA therapy using MIME for either up to 15 hours (low-dose) or 30 hours (high-dose) or received up to 15 hours of additional conventional therapy in addition to usual care (control). The primary outcome measure was the Fugl-Meyer Assessment (FMA). The secondary outcome measures were the Functional Independence Measure (FIM), Wolf Motor Function Test, Motor Power, and Ashworth scores at intake, discharge, and 6-month follow-up. Mean duration of study treatment was 8.6, 15.8, and 9.4 hours for the low-dose, high-dose, and control groups, respectively. Gains in the primary outcome measure were not significantly different between groups at follow-up. Significant correlations were found at discharge between FMA gains and the dose and intensity of RA. Intensity also correlated with FMA gain at 6 months. The high-dose group had greater FIM gains than controls at discharge and greater tone but no difference in FIM changes compared with low-dose subjects at 6 months. As used during acute rehabilitation, motor-control changes at follow-up were no less with MIME than with additional conventional therapy. Intensity of training with MIME was positively correlated with motor-control gains.

Sexuality in persons with lower extremity amputations.

PURPOSE There is a paucity of information regarding sexual functioning in persons with lower extremity amputations. The purpose of this study was to describe sexual and psychological functioning and health status in persons with lower extremity amputation. METHODS Self-report surveys assessed sexual functioning (Derogatis Inventory), depression (Beck Depression Inventory, anxiety (State-Trait Anxiety Inventory), and health status (Health Status Questionnaire) in a convenience sample of 30 men with lower extremity amputations. Mean age of the participants was 57 years (range 32-79). Mean duration since amputation was 23 months (range 3-634 months). Twenty one subjects (70%) had trans-tibial and seven subjects (23%) had trans-femoral amputations. RESULTS A majority of subjects were experiencing problems in several domains of sexual functioning. Fifty three percent (n = 16) of the subjects were engaged in sexual intercourse or oral sex at least once a month. Twenty seven percent (n = 8) were masturbating at least once a month. Nineteen subjects (63%) reported orgasmic problems and 67% were experiencing erectile difficulties. Despite these problems, interest in sex was high in over 90% of the subjects. There was no evidence of increased prevalence of depression or anxiety in these subjects when compared to other outpatient adult populations. CONCLUSIONS Sexual problems were common in the subjects studied. Despite these problems, interest in sex remained high. Few investigations have been directed toward identifying the psychological and social factors that may contribute to these problems and more research with a larger population is needed in this area.Purpose : There is a paucity of information regarding sexual functioning in persons with lower extremity amputations. The purpose of this study was to describe sexual and psychological functioning and health status in persons with lower extremity amputation. Methods : Self-report surveys assessed sexual functioning (Derogatis Inventory), depression (Beck Depression Inventory, anxiety (State-Trait Anxiety Inventory), and health status (Health Status Questionnaire) in a convenience sample of 30 men with lower extremity amputations. Mean age of the participants was 57 years (range 32-79). Mean duration since amputation was 23 months (range 3-634 months). Twenty one subjects (70%) had trans-tibial and seven subjects (23%) had trans-femoral amputations. Results : A majority of subjects were experiencing problems in several domains of sexual functioning. Fifty three percent ( n = 16) of the subjects were engaged in sexual intercourse or oral sex at least once a month. Twenty seven percent ( n = 8) were masturbating at least once a month. Nineteen subjects (63%) reported orgasmic problems and 67% were experiencing erectile difficulties. Despite these problems, interest in sex was high in over 90% of the subjects. There was no evidence of increased prevalence of depression or anxiety in these subjects when compared to other outpatient adult populations. Conclusions : Sexual problems were common in the subjects studied. Despite these problems, interest in sex remained high. Few investigations have been directed toward identifying the psychological and social factors that may contribute to these problems and more research with a larger population is needed in this area.

Characteristics of recurrent pressure ulcers in veterans with spinal cord injury.

Abstract Background/Objective: To describe characteristics of recurrent pressure ulcers (PrUs) in veterans with spinal cord injury (SCI). Design: Descriptive, cohort study. Settings and Participants: Twenty-four veterans with SCI from 6 SCI centers in the Department of Veterans Affairs. Methods: Data from a prospective study evaluating PrUs were analyzed for 24 veterans with 29 recurrent PrUs during 9 months. Additional retrospective medical record data were analyzed for 15 veterans who received inpatient treatment. Results: Participants were male, 50% non-Hispanic white, with paraplegia (63%), complete SCI (83%), a mean age of 56 years, and mean time since SCI of 21 years. Most PrUs recurred (63%, n = 15 patients) in the same location as the most recent ulcer and at the ischial tuberosities (63%). Mean time to recurrence was 16.6 weeks. PrUs were stage III (28%, n = 8) or IV (45%, n = 13) with undermining (48%), necrotic slough (50%), and minimal exudate. One third were (n = 9) larger than 16 cm2. Mean Bates-Jensen Wound Assessment Tool Score was 33.63. Inpatient medical record data (n = 15) showed 73% with documentation indicating infection treated with antibiotics (53%, n = 8 patients), osteomyelitis (47%, n = 7), and/or cellulitis (1 3%, n = 2) noted. Plastic surgery consultation was obtained for 67% with surgery as an option for 73% (1 without consultation). Scheduled repositioning was documented for 21%. Conclusions: Most PrUs were severe, located at the same anatomic site, and recurred within 4 months, suggesting that the recurrent ulcers were more likely incomplete healing of the initial PrUs. This sample of veterans with SCI provides early data on recurrent PrU characteristics.

Predictors of pressure ulcer recurrence in veterans with spinal cord injury.

Abstract Background/Objective: To predict recurrence of pressure ulcers (PrUs) in a high-risk populationofveterans with spinal cord injury (SCI). Design:Cross-sectional observational design. Participants: A convenience sample of 64 subjects from 6 Department of Veterans Affairs (VA) SCI Centers who had been admitted to the hospital for the treatment of stage III-IV pelvic PrUs and were healed at the time of discharge back to the community. Main Outcome Measures:Primary outcome measures were pelvic PrU recurrence, defined as selfreported new skin breakdown (stage II or greater) in the pelvic area (not necessarily in the same location as previous ulcer) and time to recurrence. Results:There were no differences between those with/without recurrences with regard to age, age at/level of injury, number of previous ulcers or surgery, rate of or time, to recurrence. Mean age was 56 years; most were white and men, lived at home, and had some college education. Mean time since SCI was 22 years; 28% had tetraplegia; mean number of prior pressure ulcers was 3; and almost one half had a previous ulcer in the same location. The strongest predictor of recurrence in a multivariate logistic regression was African American race (odds ratio = 9.3). Additional predictors included higher scores on the Charlson Co-Morbidity Index (indicating a higher burden of illness), the Salzburg PrU Risk Assessment Scales, and longer sitting time at discharge. Conclusion:Identifying individuals at highest risk for recurrence and developing effective prevention programs are essential rehabilitation goals. We recommend that the unique findings of this exploratory study be considered preliminary until replication of these results is published.

Factors predicting pressure ulcers in veterans with spinal cord injuries.

Smith BM, Guihan M, LaVela SL, Garber SL: Factors predicting pressure ulcers in veterans with spinal cord injuries. Am J Phys Med Rehabil 2008;87:750–757. Objectives:To identify patient risk factors for pressure ulcers in a sample of veterans with spinal cord injuries and disorders. Design:A survey incorporating questions from the Centers for Disease Control and Prevention’s Behavioral Risk Factor Surveillance System was mailed to individuals with spinal cord injuries and disorders in 2003. A multiple logistic regression model including 2574 respondents was used to examine the association between patient characteristics and the self-report of pressure ulcers. Results:Approximately 36% of respondents reported having pressure ulcers during the previous year. Respondent characteristics significantly associated with report of one or more pressure ulcers included diabetes (incidence rate ratio [IRR] = 1.36, P < 0.001), smoking (IRR = 1.16, P = 0.030), injury duration >30 yrs (IRR = 1.27, P = 0.000), and reporting frequent depressive symptoms (IRR = 1.30, P < 0.001). Veterans who did not have injuries related to their military service (IRR = 1.39, P < 0.001) or who received care at non-VA facilities in addition to or instead of VA facilities (IRR = 1.13, P = 0.024) were more likely than other veterans to report pressure ulcers. Conclusion:Efforts to prevent pressure ulcers should include increased attention to managing diabetes and depressive symptoms. Further research to explore the association between multiple healthcare system use and the risk of pressure ulcers should be pursued.

Effectiveness of mattress overlays in reducing interface pressures during recumbency.

This study evaluates the pressure-reduction characteristics of seven mattress overlays. Thirty subjects were evaluated on each support surface to determine the interface pressures that are generated under the most common pressure sore sites. The results of this study indicate that there is great variability in the effectiveness of traditional mattress overlays. The most effective overlays are the Roho and Akros DFD mattresses; whereas 2-inch thick convoluted foam provides no significant protection for the trochanter when the subjects were lying on their sides (lateral position).

Conducting intervention research among underserved populations: lessons learned and recommendations for researchers.

Randomized controlled trials (RCTs) are considered the criterion standard in research design for establishing treatment efficacy. However, the rigorous and highly controlled conditions of RCTs can be difficult to attain when conducting research among individuals living with a confluence of disability, low socioeconomic status, and being a member of a racial/ethnic minority group, who may be more likely to have unstable life circumstances. Research on effective interventions for these groups is urgently needed, because evidence regarding approaches to reduce health disparities and improve health outcomes is lacking. In this methodologic article, we discuss the challenges and lessons learned in implementing the Lifestyle Redesign for Pressure Ulcer Prevention in Spinal Cord Injury study among a highly disadvantaged population. These issues are discussed in terms of strategies to enhance recruitment, retention, and intervention relevance to the target population. Recommendations for researchers seeking to conduct RCTs among socioeconomically disadvantaged, ethnically diverse populations are provided.

Telerehabilitation for veterans with a lower-limb amputation or ulcer: Technical acceptability of data

A study was undertaken to determine the technical acceptability of information available via a customized telerehabilitation system regarding patients with lower-limb ulcers or recent lower-limb amputations receiving care at a Veterans Affairs Medical Center. Among the 54 participants, 57 wounds (39 ulcers, 19 amputation incisions) were evaluated by means of still photographs and skin temperature data sent via ordinary telephone lines. Three experienced clinicians served as raters. Intrarater agreements and McNemar chi(2) tests were assessed between decisions made after telerehabilitation sessions and decisions made by the same rater after in-person sessions. Interrater agreements and kappa coefficients were assessed between two raters for both telerehabilitation and in-person sessions. The intrarater agreement on 57 wounds for the primary rater was 93%, and the McNemar test indicated no significant difference in the ratings (p < 0.63). Interrater agreement on 18 wounds was 78% (kappa = 0.55, p < 0.02) for the telerehabilitation sessions and 89% (kappa = 0.77, p < 0.001) for the in-person sessions. Most qualitative comments by three clinicians on picture quality (54/63 = 86%) and temperature data (39/44 = 88%) were favorable (good to excellent). The information yielded from this study provides evidence that the telerehabilitation system has the potential to present sufficient information to experienced clinicians so they can make informed decisions regarding wound management. The next phase of the study will include in-home trials and improvements in the technology.

Association of hemoglobin levels, acute hemoglobin decrease, age, and co-morbidities with rehabilitation outcomes after total knee replacement.

Wang X, Rintala DH, Garber SL, Henson H: Association of hemoglobin levels, acute hemoglobin decrease, age, and co-morbidities with rehabilitation outcomes after total knee replacement. Am J Phys Med Rehabil 2005;84:451–456. Objective:A study was undertaken to assess the association of preoperative and postoperative hemoglobin levels with rehabilitation outcomes, age, and selected co-morbidities Design:Charts of 49 patients admitted to rehabilitation after total knee arthroplasty due to degenerative joint disease were reviewed. Outcome measures included rehabilitation admission and discharge motor FIM™ scores, motor FIM gain, and rehabilitation length of stay. Results:Patients with higher preoperative hemoglobin levels had higher rehabilitation admission motor FIM scores (r = 0.38, P < 0.01) and lower motor FIM gains (r = −0.45, P < 0.001). Patients who had higher hemoglobin levels at rehabilitation admission had higher admission motor FIM scores and shorter length of stay. Patients with diabetes had lower preoperative hemoglobin levels. Patients with hypertension had longer length of stay. Older patients had lower admission and discharge motor FIM scores and longer length of stay. Conclusions:Patients admitted to rehabilitation after total knee replacement have the potential to improve motor function, regardless of their preoperative and rehabilitation admission hemoglobin levels and the decrease in hemoglobin levels. However, those admitted to rehabilitation with lower hemoglobin levels, those with lower admission motor FIM scores, those who are older, and those who have hypertension may expect longer hospital stays to reach their functional goals.

Implementing trials of complex interventions in community settings: The USC – Rancho Los Amigos Pressure Ulcer Prevention Study (PUPS)

Background Randomized trials of complex, non-pharmacologic interventions implemented in home and community settings, such as the University of Southern California (USC)-Rancho Los Amigos National Rehabilitation Center (RLANRC) Pressure Ulcer Prevention Study (PUPS), present unique challenges with respect to (1) participant recruitment and retention, (2) intervention delivery and fidelity, (3) randomization and assessment, and (4) potential inadvertent treatment effects. Purpose We describe the methods employed to address the challenges confronted in implementing PUPS. In this randomized controlled trial, we are assessing the efficacy of a complex, preventive intervention in reducing the incidence of, and costs associated with, the development of medically serious pressure ulcers in people with spinal cord injury. Methods Individuals with spinal cord injury recruited from RLANRC were assigned to either a 12-month preventive intervention group or a standard care control group. The primary outcome is the incidence of serious pressure ulcers with secondary endpoints including ulcer-related surgeries, medical treatment costs, and quality of life. These outcomes are assessed at 12 and 24 months after randomization. Additionally, we are studying the mediating mechanisms that account for intervention outcomes. Results PUPS has been successfully implemented, including recruitment of the target sample size of 170 participants, assurance of the integrity of intervention protocol delivery with an average 90% treatment adherence rate, and enactment of the assessment plan. However, implementation has been replete with challenges. To meet recruitment goals, we instituted a five-pronged approach customized for an underserved, ethnically diverse population. In intervention delivery, we increased staff time to overcome economic and cultural barriers to retention and adherence. To ensure treatment fidelity and replicability, we monitored intervention protocol delivery in accordance with a rigorous plan. Finally, we have overcome unanticipated assessment and design concerns related to (1) determining pressure ulcer incidence/severity, (2) randomization imbalance, and (3) inadvertent potential control group contamination. Limitations We have addressed the most daunting challenges encountered in the recruitment, assessment, and intervention phases of PUPS. Some challenges and solutions may not apply to trials conducted in other settings. Conclusions Overcoming challenges has required a multifaceted approach incorporating individualization, flexibility, and persistence, as well as the ability to implement needed mid-course corrections.