- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07578051
Impairment Oriented Versus Task Oriented Gait Training In Transfemoral Amputee Rehabilitation.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants were randomly assigned into two groups. Group A ,which focus on strengthening exercises such as ,side lying hip abductor strengthening ,prone lying hip extensors strengthening ,supine lying hip flexors strengthening ,side lying hip adductors strengthening and bridging .Each exercise should be hold for 10-20 seconds with 10 repetition .
Group B , which prioritise functional activities and real life task such as lateral trunk bending with crossed leg ,stepping over obstacle ,lateral step ups ,walk with visual markers on floor,sit to stand focus on glutes activation .
Corrective exercises will be performed by both groups . Outcome measures include spatiotemporal parameters and Amputee Mobility Predictor (AMP).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Quratulain Saeed, MS-OMPT
- Phone Number: 03315562889
- Email: quratulain.saeed@fui.edu.pk
Study Contact Backup
- Name: Saliha Bibi, DPT
- Phone Number: 03171501156
- Email: bibisaliha1293@gmail.com
Study Locations
-
-
Punjab Province
-
Islamabad, Punjab Province, Pakistan, 46000
- Recruiting
- Foundation University College of Physical Therapy
-
Contact:
- Quratulain Saeed, MS-OMPT
- Phone Number: 03315562889
- Email: quratulain.saeed@fui.edu.pk
-
Contact:
- Saliha Bibi, DPT
- Phone Number: 03171501156
- Email: bibisaliha1293@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18-40 years
- Unilateral transfemoral amputees
- Cleared by physicians for participation in physical therapy
- Willing
Exclusion Criteria:
- Residual limb complication that interfere with mobility
- History of neurological disorders
- Any joint complication in intact limb
- Currently enrolled in another research study
- Mild to severe cognitive impairment (MoCA) i.e , score less than 25 , Uncontrolled diabetes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Impairment oriented group A
Group A will receive :
|
Participants will receive ten days training programs with 5 days in each week. Each session will include warm up followed by sit to stand , stand to sit, walking in parallel bars ,ascend and descend stairs. Participants with group A will receive strengthening exercises of hip flexor , abductors, adductors and bridging of 10 repetition with 10-20 second hold according to patient. |
|
Experimental: Task oriented group B
Group B will receive :
|
Participants will receive ten days training programs with 5 days in each week. Each session will include warm up followed by sit to stand , stand to sit, walking in parallel bars ,ascend and descend stairs. Participants with group B will receive lateral trunk bending, stepping over obstacle, lateral step ups, walk with visual markers on floor, sit to stand focus on glutes activation. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Amputee Mobility Predictor (AMP)
Time Frame: on 3rd and 10th day.
|
AMP is functional scale utilising a 3 point rating scale of 0-2.AMP scores have been correlated with functional medicare classification levels of 0-4.
|
on 3rd and 10th day.
|
|
Gait speed
Time Frame: on 3rd and 10th day of treatment
|
Gait speed in meters per second , measured with 10 meter walking test, gait speed computed by dividing distance covered by time taken to cover it .
(m/s)
|
on 3rd and 10th day of treatment
|
|
cadence
Time Frame: On the 3rd day of treatment and 10th day of treatment
|
The number of steps taken per minute during walking, measured in steps per minute (steps/min )
|
On the 3rd day of treatment and 10th day of treatment
|
|
Cycle time
Time Frame: On the 3rd day of treatment and 10th day of treatment
|
The time required to complete one full gait cycle from the initial contact of one foot to the next initial contact of same foot, measured in seconds (s)
|
On the 3rd day of treatment and 10th day of treatment
|
|
Stride length
Time Frame: On the 3rd day of treatment and 10th day of treatment
|
Distance between two consecutive heel strikes of same foot , measures in meter (m)
|
On the 3rd day of treatment and 10th day of treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Saliha Bibi, DPT, Foundation University Islamabad
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FUI/FUCP/CTR/07.26/SalihaBibi
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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