Wristband Accelerometers to motiVate arm Exercises after Stroke (WAVES): a pilot randomized controlled trial

Ruth H. Da-Silva, Sarah A. Moore, Helen Rodgers, Lisa Shaw, Louise Sutcliffe, Frederike van Wijck, Christopher I. Price

Research output: Contribution to journalArticle

Abstract

Objective:
To evaluate the feasibility of a multicentre, observer-blind, pilot randomized controlled trial (RCT) of a wristband accelerometer with activity-dependent vibration alerts to prompt impaired arm use after stroke.

Design:
Parallel-group pilot RCT.

Setting:
Four English stroke services.

Participants:
Patients 0–3¿months post stroke with a new arm deficit.

Intervention:
Participants were randomized to wear a prompting or ‘sham’ wristband during a four-week self-directed therapy programme with twice-weekly therapy review.

Main outcomes:
Recruitment, retention and adherence rates, safety and completion of assessments were reported. Arm recovery was measured by Action Research Arm Test (ARAT) and Motor Activity Log (MAL) without statistical comparison.

Results:
In total, 33 patients were recruited (0.6 per month/site; median time post stroke: 26¿days (interquartile range (IQR):15.5–45)). Baseline, four-week and eight-week median (IQR) ARAT for the control group (n¿=¿19) were 15 (2–35), 35 (15–26) and 31 (21–55) and those for the intervention group (n¿=¿14) were 37 (16–45), 57 (29–57) and 57 (37–57), respectively; for MAL Amount of Use, the corresponding values in the control group were 0.2 (0.0–1.2), 1.1 (0.3–2.9) and 1.2 (0.7–2.9) and in the intervention group were 1.4 (0.5–2.6), 3.8 (1.9–4.5) and 3.7 (2.1–4.3). Four participants withdrew from the study. Wristbands were worn for 79% of the recommended time. The intervention and control group participants received a median of 6.0 (IQR: 4.3–8.0) and 7.5 (IQR: 6.8–8.0) therapy reviews. A median of 8 (IQR: 6–10) prompts were delivered per intervention participant/day. Research assessments were completed for 28/29 and 25/28 patients at four and eight weeks. Eight serious adverse events were reported, all unrelated to the intervention.

Conclusion:
A multicentre RCT of wristband accelerometers to prompt arm activity early after stroke is feasible. A total sample of 108 participants would be required.
Original languageEnglish
Pages (from-to)1391-1403
Number of pages13
JournalClinical Rehabilitation
Volume33
Issue number8
Early online date7 Mar 2019
DOIs
Publication statusPublished - 1 Aug 2019

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Randomized Controlled Trials
Stroke
Exercise
Health Services Research
Control Groups
Motor Activity
Vibration
Therapeutics
Safety
Research

Keywords

  • Stroke
  • accelerometer
  • rehabilitation
  • self-directed
  • upper extremity (arm)

Cite this

Da-Silva, Ruth H. ; Moore, Sarah A. ; Rodgers, Helen ; Shaw, Lisa ; Sutcliffe, Louise ; van Wijck, Frederike ; Price, Christopher I. / Wristband Accelerometers to motiVate arm Exercises after Stroke (WAVES): a pilot randomized controlled trial. In: Clinical Rehabilitation. 2019 ; Vol. 33, No. 8. pp. 1391-1403.
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title = "Wristband Accelerometers to motiVate arm Exercises after Stroke (WAVES): a pilot randomized controlled trial",
abstract = "Objective:To evaluate the feasibility of a multicentre, observer-blind, pilot randomized controlled trial (RCT) of a wristband accelerometer with activity-dependent vibration alerts to prompt impaired arm use after stroke.Design:Parallel-group pilot RCT.Setting:Four English stroke services.Participants:Patients 0–3¿months post stroke with a new arm deficit.Intervention:Participants were randomized to wear a prompting or ‘sham’ wristband during a four-week self-directed therapy programme with twice-weekly therapy review.Main outcomes:Recruitment, retention and adherence rates, safety and completion of assessments were reported. Arm recovery was measured by Action Research Arm Test (ARAT) and Motor Activity Log (MAL) without statistical comparison.Results:In total, 33 patients were recruited (0.6 per month/site; median time post stroke: 26¿days (interquartile range (IQR):15.5–45)). Baseline, four-week and eight-week median (IQR) ARAT for the control group (n¿=¿19) were 15 (2–35), 35 (15–26) and 31 (21–55) and those for the intervention group (n¿=¿14) were 37 (16–45), 57 (29–57) and 57 (37–57), respectively; for MAL Amount of Use, the corresponding values in the control group were 0.2 (0.0–1.2), 1.1 (0.3–2.9) and 1.2 (0.7–2.9) and in the intervention group were 1.4 (0.5–2.6), 3.8 (1.9–4.5) and 3.7 (2.1–4.3). Four participants withdrew from the study. Wristbands were worn for 79{\%} of the recommended time. The intervention and control group participants received a median of 6.0 (IQR: 4.3–8.0) and 7.5 (IQR: 6.8–8.0) therapy reviews. A median of 8 (IQR: 6–10) prompts were delivered per intervention participant/day. Research assessments were completed for 28/29 and 25/28 patients at four and eight weeks. Eight serious adverse events were reported, all unrelated to the intervention.Conclusion:A multicentre RCT of wristband accelerometers to prompt arm activity early after stroke is feasible. A total sample of 108 participants would be required.",
keywords = "Stroke, accelerometer, rehabilitation, self-directed, upper extremity (arm)",
author = "Da-Silva, {Ruth H.} and Moore, {Sarah A.} and Helen Rodgers and Lisa Shaw and Louise Sutcliffe and {van Wijck}, Frederike and Price, {Christopher I.}",
note = "Acceptance from webpage AAM requested 29/8/19 ET and 13/9/19 ET Applied 'no exception' as file not received after 2 requests. ET 24/10/19",
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Wristband Accelerometers to motiVate arm Exercises after Stroke (WAVES): a pilot randomized controlled trial. / Da-Silva, Ruth H.; Moore, Sarah A.; Rodgers, Helen; Shaw, Lisa; Sutcliffe, Louise; van Wijck, Frederike; Price, Christopher I.

In: Clinical Rehabilitation, Vol. 33, No. 8, 01.08.2019, p. 1391-1403.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Wristband Accelerometers to motiVate arm Exercises after Stroke (WAVES): a pilot randomized controlled trial

AU - Da-Silva, Ruth H.

AU - Moore, Sarah A.

AU - Rodgers, Helen

AU - Shaw, Lisa

AU - Sutcliffe, Louise

AU - van Wijck, Frederike

AU - Price, Christopher I.

N1 - Acceptance from webpage AAM requested 29/8/19 ET and 13/9/19 ET Applied 'no exception' as file not received after 2 requests. ET 24/10/19

PY - 2019/8/1

Y1 - 2019/8/1

N2 - Objective:To evaluate the feasibility of a multicentre, observer-blind, pilot randomized controlled trial (RCT) of a wristband accelerometer with activity-dependent vibration alerts to prompt impaired arm use after stroke.Design:Parallel-group pilot RCT.Setting:Four English stroke services.Participants:Patients 0–3¿months post stroke with a new arm deficit.Intervention:Participants were randomized to wear a prompting or ‘sham’ wristband during a four-week self-directed therapy programme with twice-weekly therapy review.Main outcomes:Recruitment, retention and adherence rates, safety and completion of assessments were reported. Arm recovery was measured by Action Research Arm Test (ARAT) and Motor Activity Log (MAL) without statistical comparison.Results:In total, 33 patients were recruited (0.6 per month/site; median time post stroke: 26¿days (interquartile range (IQR):15.5–45)). Baseline, four-week and eight-week median (IQR) ARAT for the control group (n¿=¿19) were 15 (2–35), 35 (15–26) and 31 (21–55) and those for the intervention group (n¿=¿14) were 37 (16–45), 57 (29–57) and 57 (37–57), respectively; for MAL Amount of Use, the corresponding values in the control group were 0.2 (0.0–1.2), 1.1 (0.3–2.9) and 1.2 (0.7–2.9) and in the intervention group were 1.4 (0.5–2.6), 3.8 (1.9–4.5) and 3.7 (2.1–4.3). Four participants withdrew from the study. Wristbands were worn for 79% of the recommended time. The intervention and control group participants received a median of 6.0 (IQR: 4.3–8.0) and 7.5 (IQR: 6.8–8.0) therapy reviews. A median of 8 (IQR: 6–10) prompts were delivered per intervention participant/day. Research assessments were completed for 28/29 and 25/28 patients at four and eight weeks. Eight serious adverse events were reported, all unrelated to the intervention.Conclusion:A multicentre RCT of wristband accelerometers to prompt arm activity early after stroke is feasible. A total sample of 108 participants would be required.

AB - Objective:To evaluate the feasibility of a multicentre, observer-blind, pilot randomized controlled trial (RCT) of a wristband accelerometer with activity-dependent vibration alerts to prompt impaired arm use after stroke.Design:Parallel-group pilot RCT.Setting:Four English stroke services.Participants:Patients 0–3¿months post stroke with a new arm deficit.Intervention:Participants were randomized to wear a prompting or ‘sham’ wristband during a four-week self-directed therapy programme with twice-weekly therapy review.Main outcomes:Recruitment, retention and adherence rates, safety and completion of assessments were reported. Arm recovery was measured by Action Research Arm Test (ARAT) and Motor Activity Log (MAL) without statistical comparison.Results:In total, 33 patients were recruited (0.6 per month/site; median time post stroke: 26¿days (interquartile range (IQR):15.5–45)). Baseline, four-week and eight-week median (IQR) ARAT for the control group (n¿=¿19) were 15 (2–35), 35 (15–26) and 31 (21–55) and those for the intervention group (n¿=¿14) were 37 (16–45), 57 (29–57) and 57 (37–57), respectively; for MAL Amount of Use, the corresponding values in the control group were 0.2 (0.0–1.2), 1.1 (0.3–2.9) and 1.2 (0.7–2.9) and in the intervention group were 1.4 (0.5–2.6), 3.8 (1.9–4.5) and 3.7 (2.1–4.3). Four participants withdrew from the study. Wristbands were worn for 79% of the recommended time. The intervention and control group participants received a median of 6.0 (IQR: 4.3–8.0) and 7.5 (IQR: 6.8–8.0) therapy reviews. A median of 8 (IQR: 6–10) prompts were delivered per intervention participant/day. Research assessments were completed for 28/29 and 25/28 patients at four and eight weeks. Eight serious adverse events were reported, all unrelated to the intervention.Conclusion:A multicentre RCT of wristband accelerometers to prompt arm activity early after stroke is feasible. A total sample of 108 participants would be required.

KW - Stroke

KW - accelerometer

KW - rehabilitation

KW - self-directed

KW - upper extremity (arm)

U2 - 10.1177/0269215519834720

DO - 10.1177/0269215519834720

M3 - Article

VL - 33

SP - 1391

EP - 1403

JO - Clinical Rehabilitation

JF - Clinical Rehabilitation

SN - 0269-2155

IS - 8

ER -