Conjunct effect of supported standing and functional electrical stimulation on strength and functional mobility in acute stroke:A randomized clinical trial
To determine the conjunct effects of supported standing and functional electrical stimulation on strength and functional mobility in acute stroke.
Design
Randomized clinical trial.
Settings and conduct
Data was collected from Dr. Ajaz Ali Physical Therapy clinic, and Wahid trust hospital in Gujrat, Punjab Pakistan
Participants/Inclusion and exclusion criteria
Inclusion Criteria
1. Patients 30-65 years of age.
2. Adults with acute stroke.
3. Adults with ischemic stroke.
4. Patients able to react on verbal command.
5. Medically stable patient.
6. Patient was able to walk before stroke.
Exclusion Criteria
Patients were excluded if they have;
1. Unstable cerebral perfusion.
2. Uncontrolled diabetes mellitus, hypertension and associated cardiac problems.
3. Associated problems in the limb e.g., deep vein thrombosis.
4. Any orthopedic condition e.g., arthritis and fractures.
5. If the physiological variables (blood pressure, oxygen, heart rate, temperature) go beyond set safety limits and patients with severe fatigue.
Intervention groups
Group A: Receiving both Functional electrical stimulation and weight bearing along with conventional therapy.
Group B: Receiving early weight bearing along with conventional therapy
Main outcome variables
Strength
Functional Mobility
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190828044636N1
Registration date:2021-01-31, 1399/11/12
Registration timing:retrospective
Last update:2021-01-31, 1399/11/12
Update count:0
Registration date
2021-01-31, 1399/11/12
Registrant information
Name
Sadia Iftikhar
Name of organization / entity
Riphah International University
Country
Pakistan
Phone
+92 53 3515229
Email address
drsipt@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-10, 1396/12/19
Expected recruitment end date
2018-09-15, 1397/06/24
Actual recruitment start date
2018-03-10, 1396/12/19
Actual recruitment end date
2018-09-25, 1397/07/03
Trial completion date
2018-12-10, 1397/09/19
Scientific title
Conjunct effect of supported standing and functional electrical stimulation on strength and functional mobility in acute stroke:A randomized clinical trial
Public title
Effects of Supported Standing and Functional Electrical Stimulation in acute stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 30-65 years of age.
Adults with acute stroke.
Adults with ischemic stroke.
Patients able to react on verbal command.
Medically stable patient.
Patient was able to walk before stroke.
Exclusion criteria:
Unstable cerebral perfusion.
Uncontrolled diabetes mellitus, hypertension and associated cardiac problems.
Associated problems in the limb e.g., deep vein thrombosis
Any orthopedic condition e.g., arthritis and fractures.
If the physiological variables (blood pressure, oxygen, heart rate, temperature) go beyond set safety limits and patients with severe fatigue
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
58
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
simple random sampling technique was used .Computer generated randomization technique using the online sequence number generator for random allocation of patients in two groups has been used to collect the data.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional review board of Riphah International University Lahore campus
Street address
28-M,Quaid-e-Azam, Industrial Estate, Kot Lakhpat, Lahore
City
Lahore
Postal code
54000
Approval date
2018-03-10, 1396/12/19
Ethics committee reference number
Ref.NO.RCRS-RE-MS-NMPT/spring2018/002
Health conditions studied
1
Description of health condition studied
stroke
ICD-10 code
I63
ICD-10 code description
Cerebral infarction
Primary outcomes
1
Description
Strength
Timepoint
Baseline(before intervention) , After 6 weeks of intervention
Method of measurement
Manual muscle testing,The River Mead Mobility Index
Secondary outcomes
1
Description
Balance and Functional mobility
Timepoint
Baseline(before intervention), After six weeks of intervention
Method of measurement
Berge Balance Scale
Intervention groups
1
Description
Intervention group:Group A: Participents were treated with conventional therapy (positioning, ROM exercises, bed mobility exercises) along with FES(Functional Electrical Stimulation) and supported standing by using tilt table initially later on standing frames and walkers for 30 minutes once a day and five times a week for six weeks.Stimulation was applied by two channel comfy stimulators (model no EV-806).stimulations was applied by surface electrodes. Electrodes were applied at the points Gluteus Maximus,QuadricepsFemoris, Tibialis Anterior for 10 minutes each. Stimulation was applied at pulse rate of 40 Hz and pulse width of 180 µs. Group B: received conventional therapy (positioning, ROM exercises, and bed mobility exercises) along with supported standing by using tilt table initially later on standing frames and walkers for 30 minutes once a day and five times a week. Both groups received treatment for six weeks.