NCT06631014

Brief Summary

A randomized control trial of 50 patients to identify the effect of early prosthetic fitting and physical rehabilitation. Previous studies show a significant impact of early induction of prosthetic rehabilitation of amputation.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

6 months

First QC Date

October 6, 2024

Last Update Submit

October 7, 2024

Conditions

Amputation of Knee

Outcome Measures

Primary Outcomes (1)

  • World Health Organization Quality of life (WHO QOL)

    questionnaire was used to measure the impact in both groups for quality of life. The WHOQOL is a quality-of-life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. The patient's physical, psychological, social, and environmental state of health are assessed separately in WHO\_QOL known as 4 domains of questionaire. 0 points represent the worst possible state of health, while 100 points represent the best possible state of health with regard to the respective domain.

    12 Months

Study Arms (2)

Early Rehab Group

EXPERIMENTAL
Diagnostic Test: Early Rehab

Delayed Rehab Group

ACTIVE COMPARATOR
Combination Product: Delayed Rehab

Interventions

Early RehabDIAGNOSTIC_TEST

The first group of 25 Patients was fitted with Prosthesis with in 6months of duration after amputation.

Early Rehab Group
Delayed RehabCOMBINATION_PRODUCT

The 2nd group of 25 patients that was fitted with Prosthesis after the time period of 6months after amputation. No physical rehab was done during this time period including physiotherapy and prosthetic treatment. Main aim was to check the significant impact of delayed rehabilitation.

Delayed Rehab Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female below-knee amputees due to trauma and diabetes

You may not qualify if:

  • patients with comorbidities
  • old user of prosthesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mobility Rehab care, Islamabad Medical Center, Near DHQ D.I.Khan

Dera Ismāīl Khān, Khyber Pakhtunkhwa, Pakistan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dean

Study Record Dates

First Submitted

October 6, 2024

First Posted

October 8, 2024

Study Start

November 1, 2023

Primary Completion

May 1, 2024

Study Completion

December 31, 2024

Last Updated

October 8, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)