Treadmill training to improve mobility for people with sub-acute stroke: a phase II feasibility randomized controlled trial

Clin Rehabil. 2018 Feb;32(2):201-212. doi: 10.1177/0269215517720486. Epub 2017 Jul 21.

Abstract

Objective: This phase II study investigated the feasibility and potential effectiveness of treadmill training versus normal gait re-education for ambulant and non-ambulant people with sub-acute stroke delivered as part of normal clinical practice.

Design: A single-blind, feasibility randomized controlled trial.

Setting: Four hospital-based stroke units.

Subjects: Participants within three months of stroke onset.

Interventions: Participants were randomized to treadmill training (minimum twice weekly) plus normal gait re-education or normal gait re-education only (control) for up to eight weeks.

Main measures: Measures were taken at baseline, after eight weeks of intervention and at six-month follow-up. The primary outcome was the Rivermead Mobility Index. Other measures included the Functional Ambulation Category, 10-metre walk, 6-minute walk, Barthel Index, Motor Assessment Scale, Stroke Impact Scale and a measure of confidence in walking.

Results: In all, 77 patients were randomized, 39 to treadmill and 38 to control. It was feasible to deliver treadmill training to people with sub-acute stroke. Only two adverse events occurred. No statistically significant differences were found between groups. For example, Rivermead Mobility Index, median (interquartile range (IQR)): after eight weeks treadmill 5 (4-9), control 6 (4-11) p = 0.33; or six-month follow-up treadmill 8.5 (3-12), control 8 (6-12.5) p = 0.42. The frequency and intensity of intervention was low.

Conclusion: Treadmill training in sub-acute stroke patients was feasible but showed no significant difference in outcomes when compared to normal gait re-education. A large definitive randomized trial is now required to explore treadmill training in normal clinical practice.

Keywords: Gait; exercise; participation; physical therapy; rehabilitation; stroke; treadmill.

Publication types

  • Clinical Trial, Phase II
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Exercise Test
  • Exercise Therapy / methods*
  • Feasibility Studies
  • Female
  • Follow-Up Studies
  • Gait Disorders, Neurologic / etiology
  • Gait Disorders, Neurologic / physiopathology
  • Gait Disorders, Neurologic / rehabilitation*
  • Humans
  • Male
  • Middle Aged
  • Mobility Limitation
  • Psychomotor Performance / physiology*
  • Risk Assessment
  • Single-Blind Method
  • Stroke / complications*
  • Stroke / diagnosis
  • Stroke Rehabilitation / methods*
  • Time Factors
  • Treatment Outcome
  • Walking Speed*