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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06130839
Other study ID # REC/0245Saba Sheikh
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 10, 2023
Est. completion date April 10, 2024

Study information

Verified date April 2024
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study compares two approaches for rehabilitating stroke patients: Perturbation-Based Training and Bobath-Based Trunk Exercises. The perturbation based training focuses on challenging patients with unexpected movements to improve their balance and stability. While the Bobath method, concentrating on facilitating normal movement patterns. The study aims to determine which approach yields better outcomes in terms of trunk control, balance, and functional recovery for stroke patients. This study will also enable the individual to be more independent and minimize their falls.


Description:

Cerebrovascular is a leading cause of physical impairment and long-term disability in the globe. The complication of stroke is mobility impairment like balance, gait, and posture disorders. This impairment leads to a higher risk of falls, reduced ability in daily activities, and difficulty restoring the overall health and quality of life. Cerebrovascular accident is the second cause of fatality. Hence, one of the primary objectives in stroke rehabilitation is to restore postural stability and functional balance, which is a combination of dynamic, static and reactive balance. For improving postural stability and balance one such technique is the utilization of a rocker board, where a platform positioned on an unstable surface is used to challenge balance. Whilst rocker boards have been used effectively for, postural stability, injury prevention, rehabilitation and balance enhancement. Improvements in rocker board performance may be attributable to one or more of the following: muscle strengthening, enhanced intersegmental coordination, increase in brain activity in the supplementary motor area and/or enhanced feed-forward and feed-backward postural control mechanisms.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date April 10, 2024
Est. primary completion date April 10, 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years to 60 Years
Eligibility Inclusion Criteria: - Able to walk with or without ambulatory aids - Able to follow commands. - Patients in the subacute and chronic stages associated with stroke hemiparesis (time since - stroke onset 6 months- 1 year) - Scoring > 21 on MMSE Exclusion Criteria: - Patients who have severe limitations in passive range of motion at lower extremities - Visual and sensory deficits - Patient who has contracture - Orthopedic or any other neurological disorder which impair balance. - Patients undergoing any other balance training protocol. - Patients with recurrent strokes - Participants who are currently participating in another clinical trial or research study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Rocker board training
Then intervention will be applied to the perturbation group as mention below at Rocker board (50 x 45 cm).the group will perform 36 sessions (4 times per week over 8 weeks) and effects of interventions will be measured before treatment, at 4th and after8th week (pre, mid and post intervention). Trunk control exercises on Rocker Board in standing position first in medio-lateral direction for 10 min and then in anterio-posterior direction for 10 min with breaks in between.
Stable surface training
the group will perform 36 sessions (4 times per week over 8 weeks) and effects of interventions will be measured before treatment, at 4th and after 8th week (pre, mid and post intervention).

Locations

Country Name City State
Pakistan LGH Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Trunk Impairment Scale It is used to measure motor impairment of the trunk after stroke. The total score for TIS ranges between 0 for a minimal performance to 23 for a perfect performance "Change will be measured from Baseline to 6 weeks" 6 weeks
Primary Timed Up and Go Test It is for the assessment of lower extremity function, mobility and fall risk. scoring criteria < 10 seconds = normal. < 20 seconds = good mobility; can walk outside alone; does not require a walking aid. < 30 seconds = walking and balance problems; cannot walk outside alone; requires walking aid. "Change will be measured from Baseline to 6 weeks" 6 weeks
Primary Postural Assessment Scale for Stroke Patient It is used for the assessments of postural control in stroke patients. It measures the ability of an individual with stroke to maintain stable postures and equilibrium during positional changes. It consists of a 4-point scale where the items are scored from 0 to 3, and the total scoring ranges from 0 to 36. "Change will be measured from Baseline to 6 weeks" 6 weeks
Primary Functional Gait Assessment It is for assessment of postural stability during walk. 3 Normal is able to ambulate for 10 steps heel to toe with no staggering. 2 Mild impairment, ambulates 7-9 steps. 1 Moderate impairment, ambulates 4-7 steps. 0 Severe impairment, ambulates less than 4 steps heel to toe or cannot perform without assistance. "Change will be measured from Baseline to 6 weeks" 6 weeks
Secondary Stroke Self-Efficacy Questionnaire It evaluate self-efficacy as a result of being able to successfully perform a specific action in stroke patients. It is a self-reported questionnaire about level of confidence reported on a 0 to 10 scale (0 = not confident, 10 = very confident) when completing 13 activities of daily life following stroke. "Change will be measured from Baseline to 6 weeks" 6 weeks
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