To determine the effects of Theraband assisted treadmill training on GAIT and balance outcomes in stroke patients
Design
single blinded, parallel group, randomized controlled trial
Settings and conduct
Post-stroke patients referred to the Rehman Medical Institute, Peshawar, during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through block randomization. This trial will be single-blinded so that the outcome assessor does not know about the intervention group.
Participants/Inclusion and exclusion criteria
Inclusion: Stroke onset >6 months, Age 30-65 years.
Exclusion: Recurrent strokes more than twice
Intervention groups
Experimental group:
• A total of 50 minutes of training will be given, which will include Treadmill training with
theraband for 30 minutes in a harness support and conventional therapy (general stretching and
strengthening exercises) for 20 minutes, 5 days a week, for a total of 4 weeks.
• 30 minutes treadmill training will be given in three sets of 10 minutes each.
with 2 minutes of rest in between.
• Participants will walk on a treadmill at a normal pace. Speed for the first 2 weeks will be 1m/s
and of the last 2 weeks will be 1.5m/s.
Control group:
• A total of 50 minutes of training will be given, which will include Treadmill training for 30
minutes in a harness support and conventional therapy (general stretching and strengthening).
exercises) for 20 minutes, 5 days a week, for a total of 4 weeks.
• 30 minutes treadmill training will be given in three sets of 10 minutes each.
with 2 minutes of rest in between.
• Participants will walk on a treadmill at a normal pace. Speed for the first 2 weeks will be 1m/s
and of the last 2 weeks will be 1.5 m/s.
Main outcome variables
Balance, Gait
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230615058491N1
Registration date:2023-11-12, 1402/08/21
Registration timing:retrospective
Last update:2023-11-12, 1402/08/21
Update count:0
Registration date
2023-11-12, 1402/08/21
Registrant information
Name
Maaham Ali
Name of organization / entity
Khyber medical university
Country
Pakistan
Phone
+92 336 8830999
Email address
maahamali99@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-18, 1402/06/27
Expected recruitment end date
2023-09-18, 1402/06/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Theraband-assisted treadmill training on balance and gait outcomes in stroke patients: A randomised controlled trial
Public title
Effects of Theraband-assisted training on balance and gait outcomes in stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Stroke onset greater than 6 months.
Age between 30-65yrs.
Ability to follow one step command, MMSE scores ≥24.
Ability to walk independently or with assistive device.
Participants who are interested and able to take part in a supervised rehabilitation program for at least 4 weeks.
Exclusion criteria:
More than one hemisphere involved.
Recurrent strokes greater than two.
Participants with any diagnosed cardiovascular illness or diabetic neuropathy.
Participants with any diagnosed neurological or musculoskeletal problems, other than stroke, that impact their gait or balance.
Participants who currently have or have previously had any diagnosed vestibular problems.
Having any diagnosed significant lower limb abnormalities (e.g. clubfoot, polio, foot drop, fractures).
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
In our trial, randomization will be conducted using a sealed envolpe method. The unit of randomization is the individual participant. For each participant, a unique identifier will be assigned, and these identifiers will be placed in separate, opaque, and sealed envelopes. The envelopes will be thoroughly mixed before a neutral third party, who is not involved in the trial, draws an envelope for each participant. The treatment assignment corresponding to the label inside the drawn envelope will determine whether the participant receives Theraband-assisted treadmill training or standard treadmill training. This method ensures the transparency and fairness of the allocation process, eliminating any potential for selection bias. Allocation concealment will be maintained throughout the trial, as the envelopes will be securely stored and opened only at the time of participant allocation
Blinding (investigator's opinion)
Single blinded
Blinding description
One physical therapist will provide the treatment session, another physical therapist will assess the pre and post Tx outcomes of the patients from both groups, outcomes assessor will be blinded in this study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
KMU AS&RB
Street address
Hayatabad phase 5
City
Peshawar
Postal code
25100
Approval date
2023-09-04, 1402/06/13
Ethics committee reference number
KMU/MSPT/NMPT/2023/1
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
G46.4
ICD-10 code description
Cerebellar stroke syndrome
Primary outcomes
1
Description
GAIT
Timepoint
Before intervention as a baseline and then at the end of intervention after 4 weeks
Method of measurement
10 meter walk test will be used to assess the GAIT outcome of patient. A stopwatch and a 10 m pathway will be required for the test. A score of <0.4m/s shows household ambulation, 0.4-0.8m/s shows limited community ambulation and >0.8m/s shows community ambulation.
2
Description
Balance
Timepoint
Before intervention as a baseline and then at the end of intervention after 4 weeks
Method of measurement
Functional reach test will be used to assess the balance of the participants. It will need measuring tape on the wall and patient will lean forward and score will be noted. A score of greater than 25 will be considered low risk, 15-25 moderate risk and less than 15 high risk of fall.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: • A total of 50 minutes session will be given which will include Treadmill training with theraband for 30 minutes in a harness support and conventional therapy (general stretching & strengthening exercises) for 20 minutes, 5 days a week for a total of 4 weeks.• 30 minutes treadmill training will be given in three sets each of 10 minutes (8 minutes training with 2 minutes rest in between).• Participants will walk on treadmill at a normal pace. Speed for the first 2 weeks will be 1m/s and of the last 2 weeks will be 1.5m/s. • Two theraband will be used, green color theraband will be used to assist dorsiflexion, while the black theraband will be tied to an abdominal belt crossing in front of the ankle, back of the knee and front of the hip joint.
Category
Treatment - Other
2
Description
Control group: • A total of 50 minutes session will be given which will include Treadmill training for 30 minutes in a harness support and conventional therapy (general stretching & strengthening exercises) for 20 minutes, 5 days a week for a total of 4 weeks.• 30 minutes treadmill training will be given in three sets each of 10 minutes (8 minutes training with 2 minutes rest in between).• Participants will walk on treadmill at a normal pace. Speed for the first 2 weeks will be 1m/s and of the last 2 weeks will be 1.5m/s.