Stroke Inpatients Rehabilitation Reinforcement of Activity

Stroke Clinical Trial

Official title:

Stroke Inpatients Rehabilitation With Accelerometer-based Feedback Reinforcement of Activity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01891565
• Other study ID #: 2013-001
• Status: Not yet recruiting
• Phase: N/A
• First received: June 26, 2013
• Last updated: June 28, 2013
• Start date: July 2013
• Est. completion date: July 2015

Study information

• Verified date: June 2013
• Source: University of Ibadan
• Contact: Mayowa O Owolabi
• Email: mayowaowolabi[@]yahoo.com
• Is FDA regulated: No
• Health authority: Nigeria: The National Agency for Food and Drug Administration and Control
• Study type: Interventional

Clinical Trial Summary

The amount of active therapy provided to patients on an inpatient stroke rehabilitation unit has been reported as often insufficient. Observational studies have found that in the first 14 days post stroke, patients receive very little therapy and have very low activity levels. More opportunity to practice may, however, improve short-term outcomes such as the level of mobility, endurance, use of the affected arm and leg, and length of stay. The Stroke Inpatient Rehabilitation Reinforcement of ACTivity (SIRRACT) trial will utilize sensors that reveal the type, quantity, and aspects of quality of patient activities outside of the confines of research laboratories. SIRRACT will deploy inexpensive Personal Activity Monitors (PAMs), comprised of triaxial accelerometers worn on the thighs.

The objectives of the study are:

i. To assess the impact of feedback from Personal Activity Monitors (PAM)s on amount of active practice, walking speed and distance in stroke patients undergoing rehabilitation.

ii. To assess the impact of feedback from PAMs on physical, psycho-emotional, cognitive and ecosocial Health-Related Quality of Life of stroke patients undergoing rehabilitation.

iii. To assess the acceptability of thigh-strapped accelerometer use among stroke patients undergoing rehabilitation.

iv. To assess the reliability and validity of thigh-strapped accelerometer use among stroke patients undergoing rehabilitation.

Hypotheses In moderate to severely disabled subjects who are receiving in-patient rehabilitation, daily feedback from PAMs about purposeful activity will increase the amount of active practice by >30%, a higher proportion of subjects who reach the level of independence for walking, and increase walking speed by 25%, leading to higher mean walking speeds and distances at the time of discharge from inpatient rehabilitation. Daily feedback from PAMs on increase in walking speed and distances will improve physical, psychological, cognitive and ecosocial domains of Health-related quality of life.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Admission for acute inpatient neurorehabilitation of a first stroke (or second stroke after full recovery from prior Transient Ischemic Attack/Stroke).

• Time from onset of stroke to admission for rehabilitation <35 days.

• Stroke from any cause (thrombotic infarct, cardioembolism, intracerebral hemorrhage) that includes unilateral hemiparesis. Hemiparesis means less than or equal 4/5 strength by the British Medical Council scale for hip flexion tested supine and for knee or ankle flexion and extension (scores less than or equal 22 of 25)

• Ability to follow simple instructions, especially to understand verbal reinforcement about activity.

• Independent in mobility prior to admission.

• Able to walk with no more than physical assistance of 2 persons for at least 3 meters. Subjects can use any type of assistive device and brace needed.

• Able to understand and repeat information related to the Informed Consent

Exclusion Criteria:

• Current medical disease that will limit physical therapy at the time of randomization or limited walking prior to the stroke, such as serious infection, Deep Vein Thrombosis, orthostatic hypotension, > stage 2 decubitus ulcer of buttocks or legs, congestive heart failure, claudication, and pain with weight-bearing or walking. Subjects can be entered if a complication resolves within 7 days of admission screening.

• Aphasia with inability to follow 2-step directions during therapeutic instructions or answers Yes/No to questions with greater than or equal 75% accuracy related to personal health and symptoms.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Feedback

Locations

Country	Name	City	State
Nigeria	University College Hospital	Ibadan	Oyo

Sponsors (1)

Lead Sponsor	Collaborator
University of Ibadan

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in walking speed		Baseline, Two weeks, Discharge, 1 month	No
Primary	Change in Health-Related Quality of Life as measured using HRQOLISP-26		Baseline, Two weeks, Discharge, 1 month	No