To determine the effect of core stability exercises on energy expenditure in stroke patients.
Design
A Randomized controlled trial
Settings and conduct
A study will be conducted at Rehman Medical Institute, Peshawar. Outcome assessor will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
• Stroke patients between 30 to 55 years of age
• Both ischemic and hemorrhagic stroke.
• Patients who experienced a single stroke.
• Patients who can walk for 10 minutes on ground at a comfortable speed(with or without assistive device)
• Patients having MMSE score of 24 or more.
Exclusion Criteria:
• Patients who has cerebellar and pontine stroke.
• Patients who has orthopedic problems.
• Patients who have vertigo, dizziness, angina or resting heart rate is not between 40-100bpm range.
• Patients who cannot follow instructions given by the therapist.
Intervention groups
Control Group: Control group will receive the conventional physical therapy program for the stroke 20 minutes a day for 5 days a week. Conventional group will receive motor relearning program protocol.
Experimental group: Experimental group each participant will have to attend a 6-weeks program of core stability exercises with 5 minutes each exercise, 5 days a week along with conventional physical therapy. Core stability exercises includes: 1. Bridging exercises 2. Unilateral pelvic bridging 3. Abdominal drawing in maneuver with leg lifts 4. Curl up.
Main outcome variables
10 m walk test and energy expenditure will be calculated by physiologic cost index formula.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230907059376N2
Registration date:2023-10-22, 1402/07/30
Registration timing:retrospective
Last update:2023-10-22, 1402/07/30
Update count:0
Registration date
2023-10-22, 1402/07/30
Registrant information
Name
Sarmad Khattak
Name of organization / entity
Rehman Medical Institute, Peshawar
Country
Pakistan
Phone
+92 91 5838666
Email address
sarmadkhattak007@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-27, 1402/07/05
Expected recruitment end date
2023-09-30, 1402/07/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of core stability exercises on energy expenditure during gait in stroke patients
Public title
Effectiveness of core stability exercises on energy expenditure during gait in stroke patients; A randomized controlled trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Stroke patients between 30 to 55 years of age
Both ischemic and hemorrhagic stroke
Patients who experienced a single stroke.
Patients who can walk for 10 minutes on ground at a comfortable speed(with or without assistive device)
Patients having MMSE score of 24 or more.
Exclusion criteria:
Patients who has cerebellar and pontine stroke.
Patients who has orthopedic problems.
Patients who have vertigo, dizziness, angina or resting heart rate is not between 40-100bpm range.
Patients who cannot follow instructions given by the therapist
Age
From 30 years old to 55 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 lottery 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 core stability exercises or conventional physical therapy program. 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
The Randomized Controlled Trial (RCT) registry is designed to ensure complete blinding of the outcome assessor, guaranteeing the integrity and impartiality of the study's results. By maintaining strict confidentiality protocols and employing a comprehensive masking system, the registry safeguards against any potential biases that may arise from the assessor's knowledge of the intervention groups, thereby enhancing the reliability and credibility of the trial's findings.
Pre assessment will be done on baseline assessment and Post assessment will be done after 6 weeks
Method of measurement
Physiologic cost index(PCI) is an indicator of energy expenditure that includes heart rate during gait along with speed and the formula used will be energy expenditure: walking heart rate-resting heart rate/walking velocity
Secondary outcomes
empty
Intervention groups
1
Description
Control group: The control group will receive the Modified Rehabilitation Program (MRP) for stroke patients three times a week, administered by trained physical therapists.The intensity of the MRP for the control group will be adjusted based on the patients' specific functional abilities, focusing on moderate-intensity exercises and activities to facilitate gradual recovery. Each session of the MRP for the control group will last for 30 minutes, ensuring an adequate duration to engage in a variety of tailored therapeutic exercises, functional tasks, and mobility training. The MRP for the control group will encompass a comprehensive range of evidence-based physical therapy techniques, including strength-building exercises, balance and coordination drills, as well as activities targeting range of motion and flexibility, tailored to the individualized needs of stroke patients.
Category
Rehabilitation
2
Description
Intervention group: Each participant in experimental group will have to attend a 6-weeks program of core stability exercises with 5 minutes each exercise, 5 days a week along with conventional physical therapy. Core stability exercises includes: 1. Bridging exercises 2. Unilateral pelvic bridging 3. Abdominal drawing in maneuver with leg lifts 4. Curl up.