FAmily-Led RehabiliTaTion aftEr Stroke in INDia: the ATTEND pilot study.

BACKGROUND: The aim of this pilot study was to determine the feasibility of a multicenter, randomized, controlled trial in India of a family-led, trained caregiver-delivered, home-based rehabilitation intervention vs. routine care. METHODS: A prospective, randomized (within seven-days of hospital admission), blinded outcome assessor, controlled trial of structured home-based rehabilitation delivered by trained and protocol-guided family caregivers (intervention) vs. routine care alone (control) was conducted in patients with residual disability. Key feasibility measures were recruitment, acceptance and adherence to assessment procedures, and follow-up of participants over six-months. CTRI/2014/10/005133. RESULTS: A total of 104 patients from the stroke unit at Christian Medical College, Ludhiana were recruited over nine-months. Recruitment was feasible and accepted by patients and their carers. Important observations were made regarding potential unblinding of the participants, contamination of therapy between the randomized groups, organization of home visits, and resources required for a multicenter study. CONCLUSION: The pilot study established the feasibility of conducting a large-scale study of family-led, trained caregiver-delivered, home-based stroke rehabilitation in a low resource setting. The main phase of the trial 'ATTEND' is currently underway in over 10 centers in India.

Mirror therapy in unilateral neglect after stroke (MUST trial): a randomized controlled trial.

OBJECTIVE: We explored the effectiveness of mirror therapy (MT) in the treatment of unilateral neglect in stroke patients. METHODS: This is an open, blinded endpoint, randomized controlled trial carried out from January 2011 to August 2013. We included stroke patients with thalamic and parietal lobe lesions with unilateral neglect 48 hours after stroke. Patients were randomized to the MT group or the control group (sham MT), and both the groups received limb activation. Patients received treatment for 1-2 hours a day 5 days a week for 4 weeks. The primary outcome was unilateral neglect assessed by a blinded assessor using the star cancellation test, the line bisection test, and a picture identification task at 1, 3, and 6 months. This study was registered at http://clinicaltrials.gov (NCT 01735877). RESULTS: Forty-eight patients were randomized to MT (n = 27) or the control group (n = 21). Improvement in scores on the star cancellation test over 6 months was greater in the MT group (mean difference 23, 95% confidence interval [CI] 19-28; p < 0.0001). Similarly, improvement in the MT group was observed in the scores on the picture identification task (mean difference 3.2, 95% CI 2.4-4.0; p < 0.0001) and line bisection test (mean difference 8.6, 95% CI 2.7-14.6; p = 0.006). CONCLUSIONS: In patients with stroke, MT is a simple treatment that improves unilateral neglect. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for patients with neglect from thalamic and parietal lobe strokes, MT improves neglect.

Shoulder taping reduces injury and pain in stroke patients: randomized controlled trial.

OBJECTIVES: We aimed to study the effectiveness of shoulder taping and conventional treatment vs sham taping and conventional treatment in prevention of shoulder injuries in patients with acute stroke. METHODS: This study was a multicenter, interventional, prospective, randomized, outcome-blinded trial (PROBE design). All first-ever stroke patients were included within 48 hours of stroke onset (August 2009-October 2011). The treatment group included shoulder taping and conventional treatment, and the control group received sham taping and conventional treatment. Primary outcomes were changes in visual analog scale (VAS) and shoulder pain and disability index (SPADI), and secondary outcomes were changes in shoulder range of motion (flexion and abduction) at days 14 and 30. Clinical trials registration no. NCT 01062308. RESULTS: There were 80 patients in the treatment arm and 82 in the control arm. There was a better reduction of VAS (on day 14: mean difference 3.7 mm, p = 0.45; on day 30: 11.9 mm, p = 0.03) and SPADI scores (on day 14: mean difference 3.5, p = 0.33; on day 30: 9.3, p = 0.04) in the treatment arm. CONCLUSIONS: Although there was a trend toward pain reduction and functional improvement associated with shoulder taping for 2 weeks after acute stage of stroke, this did not reach statistical significance. The long-term effects of taping need to be studied in large trials. CLASSIFICATION OF EVIDENCE: This study provided Class III evidence that tri-pull shoulder taping was ineffective in significantly reducing shoulder pain in patients with acute stoke.

Complementary and alternative medicine treatments among stroke patients in India.

BACKGROUND: Complementary and alternative medicine (CAM) is commonly used by persons with stroke throughout the world, particularly in Asia. OBJECTIVE: The objectives of this study were to determine the frequency of CAM use and the factors that predict the use of CAM in stroke patients. METHODS: This study was carried out in the stroke units of Christian Medical College, Ludhiana, and Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, India, from June 2010 to December 2010. Participants were interviewed using a structured questionnaire (≥ 6 months post stroke). Outcomes were assessed using a modified Rankin Scale (mRS). RESULTS: Three hundred fourteen stroke patients were interviewed; mean age was 57.4 ± 12.9 years, and 230 (73.2%) patients were men. Of 314 patients, 114 (36.3%) had used the following CAM treatments: ayurvedic massage, 67 (59.3%); intravenous fluids, 22 (19.5%); herbal medicines, 17 (15%); homeopathy, 15 (13.3%); witchcraft, 3 (2.7%); acupuncture, 3 (2.7%); opium intake, 10 (8.8%); and other nonconventional treatments, 10 (8.8%). Patients with severe stroke (P < .0001), limb weakness (P < .0001), dysphagia (P = .02), dyslipidemia (P = .007), hypertension (P = .03), or hemorrhagic stroke (P<.0001) and patients with poor outcome (mRS >2;P < .0001) often used CAM treatments. CONCLUSION: More than one-third of the patients in this study opted for CAM. Presence of limb weakness, dysphagia, dyslipidemia, hypertension, hemorrhagic stroke, severe stroke, and poor outcome predicted the use of CAM.

Preemptive antiemesis in patients undergoing modified radical mastectomy: oral granisetron versus oral ondansetron in a double-blind, randomized, controlled study.

STUDY OBJECTIVE: To assess the efficacy of oral granisetron versus oral ondansetron for preemptive antiemesis in women undergoing modified radical mastectomy. DESIGN: Randomized, double-blind, controlled study. SETTING: Metropolitan hospital. PATIENTS: Ninety ASA physical status I and II hospitalized female patients, aged 18 to 65 y, scheduled for modified radical mastectomies. INTERVENTIONS: Patients were assigned to receive orally placebo, granisetron 2 mg, or ondansetron 4 mg (n = 30 in each group) 1 h before induction of anesthesia. A standard general anesthetic technique and postoperative analgesia were used. MEASUREMENTS: Postoperative nausea and vomiting and safety assessments were performed continuously 0 to 2, 2 to 6, 6 to 12, and 12 to 24 h after anesthesia. MAIN RESULTS: A complete response during 0 to 2 h after anesthesia was found in 43%, 63%, and 90% of patients who had received placebo, granisetron, or ondansetron, respectively; corresponding percentages of patients requiring rescue antiemetics were 40%, 17%, and 7%. Frequency of nausea and vomiting was low (less than 23%) after 2 h in the three groups. Observations of postoperative nausea and vomiting score and need for antiemetics at other time intervals (2 to 6, 6 to 12, and 12 to 24 h) were not significantly different among the three groups. CONCLUSION: Oral ondansetron 4 mg provided better preemptive antiemesis than oral granisetron 2 mg in the 2 h after modified radical mastectomy during general anesthesia.

The analgesic effects of preemptive gabapentin in patients undergoing surgery for brachial plexus injury--a preliminary study.

There are reports indicating that gabapentin may have place in the treatment of postoperative pain. No study has evaluated the effects of gabapentin on acute, postoperative pain in patients undergoing surgery for brachial plexus injuries. In this preliminary study, we evaluated gabapentin as preemptive analgesic for intraoperative period and during the acute postoperative period at rest and during movement. Twenty consecutive adult patients undergoing surgery for brachial plexus injury were enrolled for the study. Patients randomly received either oral gabapentin 800 mg or placebo capsules 2 hours before surgery. General anesthesia was induced and maintained with propofol, at bispectral index value between 40 and 60. Intraoperative fentanyl and propofol requirements were noted. Postoperatively, all patients were alert and pain was assessed using visual analog scale (VAS) for 24 hours, both during rest and movement. Whenever VAS score was more than 50 or on patients' demand, ketorolac 30 mg was given as rescue analgesic. The demographics, duration of surgery, and propofol consumption in both groups were comparable. Intraoperative and postoperative heart rate and mean blood pressure were also comparable. Significant difference was noted in intraoperative fentanyl consumption (P=0.03), total dose of rescue analgesic (P=0.004), and VAS score at rest and movement, between the 2 groups; less in gabapentin group as compared with placebo group (P=0.01 and 0.04, at rest and movement, respectively). A single oral dose of gabapentin 800 mg, as preemptive analgesic in patients undergoing surgery for brachial plexus injury is found to be an effective adjunct to intraoperative and postoperative pain. Pain is reduced not only at rest but also during movement.

Hemodynamic and bispectral index changes following skull pin attachment with and without local anesthetic infiltration of the scalp.

We studied the hemodynamic and bispectral index (BIS) changes in 44 patients undergoing cervical diskectomy with attachment of a Gardner-Wells tong (with two sharp conical pins) to the skull to facilitate intraoperative bone graft insertion. Patients were induced with fentanyl, thiopentone, and rocuronium and maintained with 66% nitrous oxide and 0.5% isoflurane, Before insertion of the pins, patients were randomly allocated to have either saline or lidocaine infiltration of the scalp at the proposed pin sites. Two minutes later, the pins were driven into the scalp. The BIS, mean arterial pressure (MAP), and heart rate (HR) were recorded before (baseline) and at 30, 60, 90, and 120 s after pin insertion. Data were compared with the baseline values and between the groups. A significant increase in MAP and HR occurred throughout the study period in the saline group. Skull pinning increased BIS throughout the study period in the saline group only, with maximal increases observed at 90 and 120 s (66.1 +/- 6.3 at 90 s and 65.7 +/- 6.4 at 120 s versus a baseline value of 62 +/- 8, P < 0.001). The increase in BIS was significant in the saline group compared with the lidocaine group at each time point. In conclusion, increases in MAP, HR, and BIS produced by skull pinning were prevented by prior local anesthetic infiltration.

Is phenytoin administration safe in a hypothermic child?

A male neonate with a Chiari malformation and a leaking myelomeningocoele underwent ventriculoperitoneal shunt insertion followed by repair of myelomeningocoele. During anaesthesia and surgery, he inadvertently became moderately hypothermic. Intravenous phenytoin was administered during the later part of the surgery for seizure prophylaxis. Following phenytoin administration, the patient developed acute severe bradycardia, refractory to atropine and adrenaline. The cardiac depressant actions of phenytoin and hypothermia can be additive. Administration of phenytoin in the presence of hypothermia may lead to an adverse cardiac event in children. As phenytoin is a commonly used drug, clinicians need to be aware of this interaction.