AmputationNCT05180682
Effectiveness of Supervised Training Program on Mobility and Balance Confidence in Individual With Lower Limb Amputation
A study testing Gait Training in people with Amputation, run by NCS University System at 1 site in Pakistan.
Trial summary
It was quasi experimental study where the researchers assess the effectiveness of supervised training program on mobility and balance confidence in individual with lower limb amputation. Read more about this study
- Who is it for?
- Ages 15 to 55 years
- Conditions the study is for
- Amputation
- What is being tested?
- Gait Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 sitePakistan
- Study dates
- 12 Mar 2021to 23 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age range 15-55 years.
- Both genders: (male and females).
- Trans-tibial amputation
- Patients involved in prosthetic rehabilitation (strengthening, balance training, stretching exercises and gait training).
Who cannot join
- Patient with cognitive problem.
- Infection
- Neuromas
- Limb swelling
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pakistan Institute of Prosthetic and Orthotic Sciences, Peshawar
Peshawar, Khyber Pakhtunkhwa, 25000
About this study
Official title: Effectiveness of Supervised Training Program on Mobility and Balance Confidence in Individual With Lower Limb Amputation: A Quasi-Experimental Study
It was quasi experimental study where the researchers assess the effectiveness of supervised training program on mobility and balance confidence in individual with lower limb amputation.
- Conditions
- Amputation
- Being tested
- Gait Training
- Keywords
- Lower limb Amputation, Balance, Mobility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait TrainingOther
the physical therapist will provide different protocol at different weeks in the following way.
first week: first fitting and initial Gait training second week: Specific Gait Training third week: Advance Gait Training fourth week: Functional Training
| Study group | Role | What they receive |
|---|---|---|
| Supervised | Experimental | This group training was supervised by the health care provider. Receives: Other: Gait Training |
| Non-Supervised | Active comparator | This group was non-supervised. Receives: Other: Gait Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance confidence
Balance was assessed through Activity-specific balance confidence. Its a 16-item questionnaire where patients' rate their confidence while doing activities.
Scoring from 0-100 (0 is no confidence and 100 is full confidence) Paper survey, 5-10 mins for administration. No Training required.
Measured: One month
Mobility
Mobility was assessed through loco-motor capabilities index. The loco-motor capabilities index is a disease-specific, self-administered instrument for assessing locomotor abilities generally considered essential for basic and advanced ADLs of people with lower-limb amputation and an enabling factor associated with long-term prosthetic use. It is easily administered and quickly completed.
It is composed of 14 questions The LCI can be divided into two 7-item subscales that cover basic (items 1, 4, 5, 8-11) and advanced (items 2, 3, 6, 7,12-14) activities, respectively. Higher scores reflect greater locomotor capabilities with the prosthesis and less dependence on assistance. Maximum score = 56, Minimum score = 0
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start12 Mar 2021
- Primary completion18 Oct 2021
- Study completion23 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants were non randomly allocated to two groups and and were analyzed in the end of the study.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- NCS University System
- Sponsor type
- University, hospital or other
- Collaborators
- Khyber Medical University Peshawar
- Responsible party
- Principal investigator, Dr. Hazrat Bilal PT, Khyber Medical University Peshawar
- Investigators
- Hazrat Bilal, MSPT, Principal investigator, Khyber Medical University Peshawar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180682
- Sponsor's protocol ID
- KMU/IPMR/MS
- Status last verified
- Oct 2022
- First submitted
- 19 Dec 2021
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Supervised Training Program on Mobility and Balance Confidence in Individual With Lower Limb Amputation: A Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT05180682
- Acronym / sponsor ID
- KMU/IPMR/MS
- Conditions
- Amputation
- Keywords
- Lower limb Amputation, Balance, Mobility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- NCS University SystemUniversity, hospital or other
- Collaborators
- Khyber Medical University Peshawar
- Study start
- 12 Mar 2021 (actual)
- Primary completion
- 18 Oct 2021 (actual)
- Study completion
- 23 Oct 2021 (actual)
- First posted
- 6 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It was quasi experimental study where the researchers assess the effectiveness of supervised training program on mobility and balance confidence in individual with lower limb amputation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Participants were non randomly allocated to two groups and and were analyzed in the end of the study.
| Arm | Type | Receives |
|---|---|---|
| Supervised | Experimental | Other: Gait TrainingThis group training was supervised by the health care provider. |
| Non-Supervised | Active comparator | Other: Gait TrainingThis group was non-supervised. |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age range 15-55 years.
- Both genders: (male and females).
- Trans-tibial amputation
- Patients involved in prosthetic rehabilitation (strengthening, balance training, stretching exercises and gait training).
Key exclusion criteria (4 listed)
- Patient with cognitive problem.
- Infection
- Neuromas
- Limb swelling
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait Trainingthe physical therapist will provide different protocol at different weeks in the following way. first week: first fitting and initial Gait training second week: Specific Gait Training third week: Advance Gait Training fourth week: Functional Training | Other | Non-Supervised, Supervised |
Primary outcome
Balance confidence
Time frame: One month
Balance was assessed through Activity-specific balance confidence. Its a 16-item questionnaire where patients' rate their confidence while doing activities. Scoring from 0-100 (0 is no confidence and 100 is full confidence) Paper survey, 5-10 mins for administration. No Training required.
Mobility
Time frame: One month
Mobility was assessed through loco-motor capabilities index. The loco-motor capabilities index is a disease-specific, self-administered instrument for assessing locomotor abilities generally considered essential for basic and advanced ADLs of people with lower-limb amputation and an enabling factor associated with long-term prosthetic use. It is easily administered and quickly completed. It is composed of 14 questions The LCI can be divided into two 7-item subscales that cover basic (items 1, 4, 5, 8-11) and advanced (items 2, 3, 6, 7,12-14) activities, respectively. Higher scores reflect greater locomotor capabilities with the prosthesis and less dependence on assistance. Maximum score = 56, Minimum score = 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hazrat Bilal, MSPT principal investigator
Khyber Medical University Peshawar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait Training in people with Amputation, run by NCS University System at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance confidence (time frame: One month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022.