Stroke
Conditions
Keywords
Sitting balance, Stroke
Brief summary
The investigators hypothesize that application of electrical stimulation would augment the effects of exercises in patients with stroke. Combined electrical stimulation with exercises for 6 weeks would lead to earlier and greater improvement in motor functions when compared with placebo-stimulation with exercises.
Detailed description
Previous studies have shown that repeated sensory inputs from transcutaneous electrical stimulation (TES) could enhance brain plasticity and conical motor output. Home-based rehabilitation is shown to be effective in motor recovery and improvement of functional ability in stroke rehabilitation. The aim of this study was to develop a home-based rehabilitation program to investigate whether combined electrically induced sensory inputs through TES with task-related trunk training (TRTT) in a home-based program would induce earlier and/or greater improvement in, seated reaching distance and trunk control when compared with placebo TES and TRTT, or control with no active treatment in subjects with chronic stroke.
Interventions
BEHAVIORALelectrical stimulation with exercises
electrical stimulation with exercises
BEHAVIORALplacebo stimulation with exercises
placebo stimulation with exercises
Sponsors
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis with first stroke for more than 6 months 2. Discharge from all rehabilitation services 3. Ability to understand and follow commands 4. A carer able for helping the home program 5. No contraindication to assessment protocol and training
Exclusion criteria
1. Cognitive disorder with Abbreviated Mental Test less than 7 2. Unilateral neglect with Star cancellation Test less than 47 3. Sensory deficit 4. Unable to give informed consent 5. Unable to speak either Cantonese or English or Mandarin 6. Commodity that preclude them from undergoing training and assessment 7. Neurological disease other than stroke
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trunk Impairment Scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Forward Sitting Functional Reach Test | 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. |
Countries
Hong Kong
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Electrical Stimulation With Exercises electrical stimulation with exercises: electrical stimulation with exercises | 12 |
| Placebo Stimulation With Exercises placebo stimulation with exercises: placebo stimulation with exercises | 13 |
| Control No active treatment | 12 |
| Total | 37 |
Baseline characteristics
| Characteristic | Electrical Stimulation With Exercises | Placebo Stimulation With Exercises | Control | Total |
|---|---|---|---|---|
| Age, Continuous | 58.2 years STANDARD_DEVIATION 10.7 | 56.3 years STANDARD_DEVIATION 7.4 | 59.3 years STANDARD_DEVIATION 10.4 | 57.8 years STANDARD_DEVIATION 9.4 |
| Region of Enrollment Hong Kong | 12 participants | 13 participants | 12 participants | 37 participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 3 Participants | 10 Participants |
| Sex: Female, Male Male | 8 Participants | 10 Participants | 9 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 13 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 13 | 0 / 12 |
Outcome results
Primary
Trunk Impairment Scale
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.
Time frame: baseline, 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Electrical Stimulation With Exercises | Trunk Impairment Scale | Baseline | 13.2 units on a scale | Standard Deviation 1.8 |
| Electrical Stimulation With Exercises | Trunk Impairment Scale | After training (6-week) | 19.0 units on a scale | Standard Deviation 2.1 |
| Placebo Stimulation With Exercises | Trunk Impairment Scale | Baseline | 13.8 units on a scale | Standard Deviation 1.3 |
| Placebo Stimulation With Exercises | Trunk Impairment Scale | After training (6-week) | 18.4 units on a scale | Standard Deviation 1.5 |
| Control | Trunk Impairment Scale | Baseline | 13.9 units on a scale | Standard Deviation 2.2 |
| Control | Trunk Impairment Scale | After training (6-week) | 15.2 units on a scale | Standard Deviation 2.6 |
Comparison: Null hypothesis: No significant differences existed between the percentage of change in Trunk Impairment Scale (TIS) score among the three groups.p-value: <0.001Kruskal-Wallis
Comparison: Post-Hoc pairwise comparison comparing the effects of electrical stimulation with exercises group and placebo stimulation with exercises group. Null hypothesis: There was no significant difference existed on the changes of the Trunk Impairment Scale score between the two groups.p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Post-Hoc pairwise comparison comparing the effects of electrical stimulation with exercises group and control group.~Null hypothesis: There was no significant difference existed on the changes of the Trunk Impairment Scale score between the two groups.p-value: 0.002Wilcoxon (Mann-Whitney)
Comparison: Post-Hoc pairwise comparison comparing the effects of placebo stimulation with exercises group and control group.~Null hypothesis: There was no significant difference existed on the changes of the Trunk Impairment Scale score between the two groups.p-value: 0.003Wilcoxon (Mann-Whitney)
Secondary
Forward Sitting Functional Reach Test
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.
Time frame: baseline, 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Electrical Stimulation With Exercises | Forward Sitting Functional Reach Test | Baseline | 22.2 cm | Standard Deviation 6.9 |
| Electrical Stimulation With Exercises | Forward Sitting Functional Reach Test | After training (6 weeks) | 29.5 cm | Standard Deviation 5.2 |
| Placebo Stimulation With Exercises | Forward Sitting Functional Reach Test | Baseline | 28.7 cm | Standard Deviation 8.8 |
| Placebo Stimulation With Exercises | Forward Sitting Functional Reach Test | After training (6 weeks) | 34.1 cm | Standard Deviation 7.4 |
| Control | Forward Sitting Functional Reach Test | Baseline | 29.0 cm | Standard Deviation 9.5 |
| Control | Forward Sitting Functional Reach Test | After training (6 weeks) | 28.8 cm | Standard Deviation 7.2 |
Comparison: Null hypothesis: No significant differences existed between the percentage of change in reaching distance between the three groups.p-value: 0.055Kruskal-Wallis