Trial Outcomes & Findings for Effects of Home-based Program in Improving Sitting Balance and Upper Limb Functions in Patients With Stroke (NCT NCT01200030)

Results Overview

The Trunk impairment scale is a 2 to 4-point ordinal scale. The scale assesses static and dynamic sitting balance and trunk coordination. The maximum scores on the static sitting balance, dynamic sitting balance, and coordination subscales are 7, 10, and 6 points, respectively. The total score of Trunk impairment scale ranges between 0 and 23 points, with a higher score representing better trunk control. The static sitting balance subscale evaluated the trunk stability with both feet on the floor and with the legs crossed. The dynamic sitting balance subscale evaluated the ability to perform trunk side flexion. The coordination components evaluated the ability to selectively rotate the upper and lower parts of the trunk.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

37 participants

Primary outcome timeframe

baseline, 6 weeks

Results posted on

2019-01-04

Participant Flow

Participant milestones

Participant milestones
Measure	Electrical Stimulation With Exercises electrical stimulation with exercises: electrical stimulation with exercises (TES+ TRlT)	Placebo Stimulation With Exercises placebo stimulation with exercises: placebo stimulation with exercises (pTES+ TRlT)	Control No active treatment
Overall Study STARTED	12	13	12
Overall Study COMPLETED	12	13	12
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Home-based Program in Improving Sitting Balance and Upper Limb Functions in Patients With Stroke

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Electrical Stimulation With Exercises n=12 Participants electrical stimulation with exercises: electrical stimulation with exercises	Placebo Stimulation With Exercises n=13 Participants placebo stimulation with exercises: placebo stimulation with exercises	Control n=12 Participants No active treatment	Total n=37 Participants Total of all reporting groups
Age, Continuous	58.2 years STANDARD_DEVIATION 10.7 • n=5 Participants	56.3 years STANDARD_DEVIATION 7.4 • n=7 Participants	59.3 years STANDARD_DEVIATION 10.4 • n=5 Participants	57.8 years STANDARD_DEVIATION 9.4 • n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	10 Participants n=7 Participants	9 Participants n=5 Participants	27 Participants n=4 Participants
Region of Enrollment Hong Kong	12 participants n=5 Participants	13 participants n=7 Participants	12 participants n=5 Participants	37 participants n=4 Participants

PRIMARY outcome

Timeframe: baseline, 6 weeks

The Trunk impairment scale is a 2 to 4-point ordinal scale. The scale assesses static and dynamic sitting balance and trunk coordination. The maximum scores on the static sitting balance, dynamic sitting balance, and coordination subscales are 7, 10, and 6 points, respectively. The total score of Trunk impairment scale ranges between 0 and 23 points, with a higher score representing better trunk control. The static sitting balance subscale evaluated the trunk stability with both feet on the floor and with the legs crossed. The dynamic sitting balance subscale evaluated the ability to perform trunk side flexion. The coordination components evaluated the ability to selectively rotate the upper and lower parts of the trunk.

Outcome measures

Outcome measures
Measure	Electrical Stimulation With Exercises n=12 Participants electrical stimulation with exercises: electrical stimulation with exercises	Placebo Stimulation With Exercises n=13 Participants placebo stimulation with exercises: placebo stimulation with exercises	Control n=12 Participants No active treatment
Trunk Impairment Scale Baseline	13.2 units on a scale Standard Deviation 1.8	13.8 units on a scale Standard Deviation 1.3	13.9 units on a scale Standard Deviation 2.2
Trunk Impairment Scale After training (6-week)	19.0 units on a scale Standard Deviation 2.1	18.4 units on a scale Standard Deviation 1.5	15.2 units on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: baseline, 6 weeks

Sitting Functional Reach was used to assess the limits of stability in reaching activities. The sitting functional reach test measures how far forward, from a sitting position, a subject can bend forward to reach without losing his/her balance. A longer reaching distance indicated a better trunk control.

Outcome measures

Outcome measures
Measure	Electrical Stimulation With Exercises n=12 Participants electrical stimulation with exercises: electrical stimulation with exercises	Placebo Stimulation With Exercises n=13 Participants placebo stimulation with exercises: placebo stimulation with exercises	Control n=12 Participants No active treatment
Forward Sitting Functional Reach Test Baseline	22.2 cm Standard Deviation 6.9	28.7 cm Standard Deviation 8.8	29.0 cm Standard Deviation 9.5
Forward Sitting Functional Reach Test After training (6 weeks)	29.5 cm Standard Deviation 5.2	34.1 cm Standard Deviation 7.4	28.8 cm Standard Deviation 7.2

Adverse Events

Electrical Stimulation With Exercises

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Stimulation With Exercises

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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. Shamay Ng

The Hong Kong Polytechnic University

Phone: (852) 2766-4889

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place