Trial Outcomes & Findings for A Rehabilitation Therapy for Post-stroke Fatigue (NCT NCT02131532)

NCT ID: NCT02131532

Last Updated: 2017-09-20

Results Overview

The numbers of stroke patients involved at each stage of recruitment were reported under this outcome.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 12 participants
• Primary outcome timeframe: 3 months after the end of treatment
• Results posted on: 2017-09-20

Participant Flow

The recruitment was started in July 2014 and completed in October 2014. Participants were recruited through three approaches, including patients discharged from the Stroke Ward, patients visiting the Stroke Clinic, and those visited by the stroke nurses in the community.

Participant milestones

Measure	Psychological Intervention All participants were enrolled in this group, receiving a psychological intervention for the treatment of post-stroke fatigue.
Overall Study STARTED	12
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Psychological Intervention All participants were enrolled in this group, receiving a psychological intervention for the treatment of post-stroke fatigue.
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	1
Overall Study Other health conditions	2

Baseline Characteristics

A Rehabilitation Therapy for Post-stroke Fatigue

Baseline characteristics by cohort

Measure	Intervention Group n=8 Participants Baseline characteristics of eight participants who completed all treatment sessions
Age, Continuous	62.0 years STANDARD_DEVIATION 14.7 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United Kingdom	8 participants n=5 Participants
Fatigue Assessment Scale	26.5 units on a scale STANDARD_DEVIATION 8.0 • n=5 Participants
Case definition of post-stroke fatigue Fulfilling case definition	5 participants n=5 Participants
Case definition of post-stroke fatigue Not fulfilling case definition	3 participants n=5 Participants
Patient Health Questionnaire-9	7.6 units on a scale STANDARD_DEVIATION 4.3 • n=5 Participants
Nottingham Extended Activities of Daily Living	20.8 units on a scale STANDARD_DEVIATION 0.9 • n=5 Participants
Stroke Impact Scale - General rating of recovery	74.8 units on a scale STANDARD_DEVIATION 16.7 • n=5 Participants
Stroke Impact Scale - Physical Strength	89.06 units on a scale STANDARD_DEVIATION 9.88 • n=5 Participants
Stroke Impact Scale - Memory and Thinking	75.45 units on a scale STANDARD_DEVIATION 21.29 • n=5 Participants
Stroke Impact Scale - Emotion	65.97 units on a scale STANDARD_DEVIATION 26.13 • n=5 Participants
Stroke Impact Scale - Communication	80.36 units on a scale STANDARD_DEVIATION 23.30 • n=5 Participants
Stroke Impact Scale - Daily Activities	93.44 units on a scale STANDARD_DEVIATION 6.54 • n=5 Participants
Stroke Impact Scale - Mobility	87.50 units on a scale STANDARD_DEVIATION 15.14 • n=5 Participants
Stroke Impact Scale - Hand Function	93.75 units on a scale STANDARD_DEVIATION 9.54 • n=5 Participants
Stroke Impact Scale - Social Activity	67.85 units on a scale STANDARD_DEVIATION 24.55 • n=5 Participants

PRIMARY outcome

Timeframe: 3 months after the end of treatment

The numbers of stroke patients involved at each stage of recruitment were reported under this outcome.

Outcome measures

Measure	Intervention Group n=120 Participants Eight participants who completed all treatment sessions were included for data analysis
Feasibility of Recruitment Process Initially approached patients	120 participants
Feasibility of Recruitment Process Responding patients	49 participants
Feasibility of Recruitment Process Eligible patients	20 participants
Feasibility of Recruitment Process Consented patients	12 participants

PRIMARY outcome

Timeframe: 3 months after the end of treatment

Number of participants who completed all treatment sessions.

Outcome measures

Measure	Intervention Group n=8 Participants Eight participants who completed all treatment sessions were included for data analysis
Attendance of Treatment Sessions	8 participants

PRIMARY outcome

Timeframe: 3 months after the end of treatment

Numbers of participants who attended the booster session as planned and those who rearranged the session

Outcome measures

Measure	Intervention Group n=8 Participants Eight participants who completed all treatment sessions were included for data analysis
Feasibility of Telephone-delivered Booster Sessions Attended as planned	1 participants
Feasibility of Telephone-delivered Booster Sessions Rearranged	7 participants

PRIMARY outcome

Timeframe: 3 months after the end of treatment

Numbers of participants who completed and returned the questionnaires on time (as required) and of those who delayed the completion.

Outcome measures

Measure	Intervention Group n=8 Participants Eight participants who completed all treatment sessions were included for data analysis
Feasibility of Follow-up Assessment at Three Months After the End of Treatment On time	6 participants
Feasibility of Follow-up Assessment at Three Months After the End of Treatment Delayed	2 participants

SECONDARY outcome

Timeframe: 3 months after the end of treatment

This is the primary clinical outcome for this intervention (but clinical outcomes are all secondary outcomes for this pilot feasibility study).

The total FAS score ranges from 10 to 50, with higher scores indicating worse outcomes of fatigue severity.

Outcome measures

Measure	Intervention Group n=8 Participants Eight participants who completed all treatment sessions were included for data analysis
Fatigue Assessment Scale (FAS)	17.25 units on a scale Standard Deviation 8.56

SECONDARY outcome

Timeframe: 3 months after the end of treatment

The total PHQ-9 score ranges from 0 to 27, with higher scores indicating worse outcomes of depressive symptoms.

Outcome measures

Measure	Intervention Group n=8 Participants Eight participants who completed all treatment sessions were included for data analysis
Patient Health Questionnaire-9 (PHQ-9)	5.00 units on a scale Standard Deviation 6.32

SECONDARY outcome

Timeframe: 3 months after the end of treatment

The total NEADL score ranges from 0 to 22, with higher scores indicating better outcomes of independence.

Outcome measures

Measure	Intervention Group n=8 Participants Eight participants who completed all treatment sessions were included for data analysis
Nottingham Extended Activities of Daily Living (NEADL)	21.00 units on a scale Standard Deviation 1.07

SECONDARY outcome

Timeframe: 3 months after the end of treatment

The general rating scale on the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes of recovery.

Outcome measures

Measure	Intervention Group n=8 Participants Eight participants who completed all treatment sessions were included for data analysis
Stroke Impact Scale (SIS) - General Rating of Recovery	88.63 units on a scale Standard Deviation 15.16

SECONDARY outcome

Timeframe: 3 months after the end of treatment

The physical strength subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.

Outcome measures

Measure	Intervention Group n=8 Participants Eight participants who completed all treatment sessions were included for data analysis
SIS - Physical Strength	89.84 units on a scale Standard Deviation 12.47

SECONDARY outcome

Timeframe: 3 months after the end of treatment

The memory and thinking subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.

Outcome measures

Measure	Intervention Group n=8 Participants Eight participants who completed all treatment sessions were included for data analysis
SIS - Memory and Thinking	87.05 units on a scale Standard Deviation 18.00

SECONDARY outcome

Timeframe: 3 months after the end of treatment

The emotion subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.

Outcome measures

Measure	Intervention Group n=8 Participants Eight participants who completed all treatment sessions were included for data analysis
SIS - Emotion	84.38 units on a scale Standard Deviation 18.84

SECONDARY outcome

Timeframe: 3 months after the end of treatment

The communication subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.

Outcome measures

Measure	Intervention Group n=8 Participants Eight participants who completed all treatment sessions were included for data analysis
SIS - Communication	87.50 units on a scale Standard Deviation 17.91

SECONDARY outcome

Timeframe: 3 months after the end of treatment

The daily activities subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.

Outcome measures

Measure	Intervention Group n=8 Participants Eight participants who completed all treatment sessions were included for data analysis
SIS - Daily Activities	95.94 units on a scale Standard Deviation 5.33

SECONDARY outcome

Timeframe: 3 months after the end of treatment

The mobility subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.

Outcome measures

Measure	Intervention Group n=8 Participants Eight participants who completed all treatment sessions were included for data analysis
SIS - Mobility	91.32 units on a scale Standard Deviation 13.96

SECONDARY outcome

Timeframe: 3 months after the end of treatment

The hand function subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.

Outcome measures

Measure	Intervention Group n=8 Participants Eight participants who completed all treatment sessions were included for data analysis
SIS - Hand Function	95.63 units on a scale Standard Deviation 8.63

SECONDARY outcome

Timeframe: 3 months after the end of treatment

The social activity subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.

Outcome measures

Measure	Intervention Group n=8 Participants Eight participants who completed all treatment sessions were included for data analysis
SIS - Social Activity	82.42 units on a scale Standard Deviation 19.90

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Simiao Wu

University of Edinburgh

Phone: 0044-131-242-6371

Email: simiao.wu@ed.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place