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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06131827
Other study ID # REC/RCR &/23/0233
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 17, 2023
Est. completion date January 22, 2024

Study information

Verified date December 2023
Source Riphah International University
Contact Memona Ayesha
Phone 03129601249
Email memonaayesha66@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Stroke is defined as sudden neurological disruption of blood supply to brain. It is most common disease that causes severe disabilities like hemiparesis which is most common motor impairment that leads to persistent upper limb dysfunction. In this study we use two techniques to improve upper limb motor dysfunction and reduce spasticity. One is task-based activities which is used to improve motor function and focus on active participation rather than normal movement pattern and other is neural mobilization which aims to reduce spasticity which is most common in stroke patients.


Description:

This study will be randomized controlled trial. Participants having stroke past 6 month to 1 year and mini mental state examination score >21 will be included in this study. And participants with severe orthopedic deformity, joint pain and visual impairment will be excluded from this study. The sample size will consist of 34 participants selected through non probability convenient sampling technique, which will further be randomized through sealed envelope method and will divide into two groups .Data will be collected using assessment tools, including the Fugl Mayer assessment scale, box and block test and wolf motor function test. 17 Participants will be assigned to the interventional group (A )which will undergo neural mobilization of median nerve with task based activities .Neural mobilization technique will be performed with twenty oscillations per minute being repeated three sets of one minute respecting one minute interval for rest between each set for 4 days weekly for 6 week. while task based activities will be performed with the dosage of 45 minutes session 5 days weekly for 6 weeks and 17 participants will be assigned to control group (B )which will undergo only neural mobilization of median nerve and will receive neural mobilization with twenty oscillations per minute being repeated three sets of one minute respecting one minute interval for rest between each set for 4 days weekly for 6 weeks. After applying both interventions motor function improvement and spasticity reduction will be measured by using BBT, wolf motor scale and fugl -Meyer assessment scale and data will be analyzed through sPss Version 25.


Recruitment information / eligibility

Status Recruiting
Enrollment 34
Est. completion date January 22, 2024
Est. primary completion date January 15, 2024
Accepts healthy volunteers No
Gender All
Age group 30 Years to 55 Years
Eligibility Inclusion Criteria: - Male and female stroke patients. - 6 month to one year post stroke . - Age 30-55 - Stable patients - Mini - mental state examination>2 - Modified ashworth Scale equal<+1 Exclusion Criteria: - Orthopedic deformity - Patients undergo bottulinuminjection toxin injection - Visual impairments - Joint pain (elbow, shoulder, wrist)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Neural mobilization
Neural mobilization will be performed with twenty oscillations per minute being repeated three sets of one minute respecting one minute interval of rest between each set for 4 days weekly for six week
Task based activities
Task based activities consisted of different types task which will be performed with the dosage of 45 minute session 5 days weekly for six week.

Locations

Country Name City State
Pakistan Ripha international university 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 Box and block test It measures unilateral gross manual dexterity 6 weeks
Primary Wolf motor Function Test The Wolf Motor Function Test (WMFT) quantifies upper extremity (UE) motor ability through timed and functional tasks 6 weeks
Primary Fugl -Meyer assessment scale It measure motor ability of upper extremity 6 weeks
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