Unilateral Trans-tibial AmputeesHEARTNCT01024023
Hull Early Walking Aids for Transtibial Amputees - Randomised Control Trial (HEART)
A study testing EWA in people with Unilateral Trans-tibial Amputees, run by University of Hull at 3 sites in United Kingdom.
Trial summary
Early walking aids are routinely used in UK for rehabilitation of patients with below knee amputations. The two main walking aids used commonly in practice include the non-articulated Pneumatic Post Amputation Mobility Aid (PPAM)and the Articulated Amputee Mobility Aid (AMA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unilateral Trans-tibial Amputees
- What is being tested?
- EWA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Dec 2004to Dec 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be included in the trial if they:
- Have had a unilateral transtibial amputation but not yet received a prosthesis
- Are expected to receive a functional prosthesis
- Are at least 18 years of age
- Are able to tolerate and use an early walking aid
- Are able to be able to walk a distance of 4 metres
- Will attend Hull and East Yorkshire Hospitals NHS Trust for prosthetic rehabilitation.
- Meet the manufacturers recommendations for using the EWA's
Who cannot join
- Patients will be excluded from the trial if they:
- Have had a major amputation of the contra lateral limb.
- Are not expected to receive a functional prosthesis
- Were unable to walk, prior to their amputation, due to a medical condition e.g. spinal injury, stroke or rheumatoid arthritis
- Are unable to follow instructions and/or participate in a programme of rehabilitation.
- Do not consent to participate in the study.
- Do not meet the manufacturers recommendations for using the EWA's
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Academic Vascular Surgical Unit, University of Hull
Hull, Humberside, HU3 2JZ
Physiotherapy Department, Hull & East Yorkshire Hospitals NHS Trust
Hull, Humberside, HU3 2JZ
Department of Sports, Health & Exercise Science, University of Hull
Hull, Humberside, HU6 7RX
About this study
Official title: Hull - Early Walking Aids for Transtibial Amputees - Does an Articulated Knee Have Benefits? A Randomised Controlled Trial
Early walking aids are routinely used in UK for rehabilitation of patients with below knee amputations. The two main walking aids used commonly in practice include the non-articulated Pneumatic Post Amputation Mobility Aid (PPAM)and the Articulated Amputee Mobility Aid (AMA). There is no published evidence on whether the articulated walking aid improves knee control and shortens delivery time. This study was designed to test the hypothesis that an articulated early walking aid has benefit to transtibial amputee compared to non-articulated early walking aid.
Read the detailed description
Physiotherapists in the UK routinely use Early Walking Aids (EWA's) to enable the lower limb amputee to start to walk again as early as 5 days post amputation (Lein S. 1992). An EWA has many benefits including a reduction in oedema (Reith et al, 1992) early gait and balance training in preparation for using a prosthesis. The two EWA's most commonly used in the UK for transtibial amputees are the Pneumatic Post Amputation Mobility aid (PPAM) and the Amputee Mobility Aid (AMA). A comparison of the PPAM aid and the AMA undertaken by Longmore T (1997) reported no significant difference in energy cost, comfort or ease of use. Scott et al (2000) found the AMA to have higher interface pressures than the PPAM aid. There is however no known published evidence on whether an articulated EWA improves active knee control following prosthetic delivery and therefore shortens rehabilitation time. In addition there is no known published evidence of the effect on quality of life with the two different EWA's.
Hypothesis: An articulated Early walking aid has benefit to the transtibial amputee compared to a non- articulated EWA.
The purpose of this proposed research is to investigate whether there are any benefits to patients in using an articulated EWA.
The study will use EMG and gait analysis to determine the potential of each of the two EWA's to re-educate gait in a way that is comparable with the gait exhibited when the subject subsequently begins to use a prosthesis thus shortening rehabilitation time. Quality of life indicators will be used to determine the impact on the patient and, in addition, the length of time taken to full rehabilitation will be considered.
- Conditions
- Unilateral Trans-tibial Amputees
- Being tested
- EWA
- Keywords
- Early Walking Aid, Amputee, Trans-tibial, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EWADevice
Also called Pneumatic Post Amputation Mobility Aid - Ortho Europe Ltd,UK, Amputee Mobility Aid - Ortho Europe Ltd,UK
Suitable participants randomised to the treatment arm to receive early walking aid and rehabilitation physiotherapy will be commenced immediately. Physiotherapy will continue after they receive their definitive prosthesis till they are comfortable and safe using it, at which stage they will be discharged and no further follow up will be performed.
| Study group | Role | What they receive |
|---|---|---|
| PPAM Aid | Active comparator | Suitable participants randomised to the treatment arm will receive the non articulated pneumatic early walking aid and rehabilitation physiotherapy will be commenced immediately. Physiotherapy will continue after they receive their definitive prosthesis till they are comfortable and safe using it, at which stage they will be discharged and no further follow up will be performed. Receives: Device: EWA |
| AMA Aid | Active comparator | Suitable participants randomised to the treatment arm will receive the articulated early walking aid and rehabilitation physiotherapy will be commenced immediately. Physiotherapy will continue after they receive their definitive prosthesis till they are comfortable and safe using it, at which stage they will be discharged and no further follow up will be performed. Receives: Device: EWA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinetic and kinematic comparison of the influence of 2 different EWAs on the transfer to prosthetic rehabilitation.
Measured: Outcomes will be measured at baseline, time of EWA fitting, prosthesis fitting, 2 week post prosthesis fitting &on discharge from physiotherapy ensuring safe prosthesis use. Final visit will vary with each patient and will be analysed with outcomes.
Secondary outcomes (1)
Quality of life measurements
Measured: Outcomes will be measured at baseline, time of EWA fitting, prosthesis fitting, 2 week post prosthesis fitting &on discharge from physiotherapy ensuring safe prosthesis use. Final visit will vary with each patient and will be analysed with outcomes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startDec 2004
- Primary completionDec 2009 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unilateral Trans-tibial AmputeesStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hull
- Sponsor type
- University, hospital or other
- Collaborators
- Hull University Teaching Hospitals NHS Trust
- Investigators
- Amanda Hancock, MSc, Principal investigator, Department of Physiotherapy, Hull & East Yorkshire Hospitals NHS TrustIan C Chetter, MB ChB, FRCS, Study director, University of Hull
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01024023
- Sponsor's protocol ID
- R0081
- Acronym
- HEART
- Status last verified
- Dec 2009
- First submitted
- 25 Nov 2009
- Last updated
- 2 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Barnett C, Vanicek N, Polman R, Hancock A, Brown B, Smith L, Chetter I. Kinematic gait adaptations in unilateral transtibial amputees during rehabilitation. Prosthet Orthot Int. 2009 Jun;33(2):135-47. doi: 10.1080/03093640902751762.
PubMed 19367517
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hull - Early Walking Aids for Transtibial Amputees - Does an Articulated Knee Have Benefits? A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01024023
- Acronym / sponsor ID
- HEART / R0081
- Conditions
- Unilateral Trans-tibial Amputees
- Keywords
- Early Walking Aid, Amputee, Trans-tibial, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of HullUniversity, hospital or other
- Collaborators
- Hull University Teaching Hospitals NHS Trust
- Study start
- Dec 2004
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 2 Dec 2009 (estimated)
- 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.
Early walking aids are routinely used in UK for rehabilitation of patients with below knee amputations. The two main walking aids used commonly in practice include the non-articulated Pneumatic Post Amputation Mobility Aid (PPAM)and the Articulated Amputee Mobility Aid (AMA). There is no published evidence on whether the articulated walking aid improves knee control and shortens delivery time. This study was designed to test the hypothesis that an articulated early walking aid has benefit to transtibial amputee compared to non-articulated early walking aid.
Detailed description
Physiotherapists in the UK routinely use Early Walking Aids (EWA's) to enable the lower limb amputee to start to walk again as early as 5 days post amputation (Lein S. 1992). An EWA has many benefits including a reduction in oedema (Reith et al, 1992) early gait and balance training in preparation for using a prosthesis. The two EWA's most commonly used in the UK for transtibial amputees are the Pneumatic Post Amputation Mobility aid (PPAM) and the Amputee Mobility Aid (AMA). A comparison of the PPAM aid and the AMA undertaken by Longmore T (1997) reported no significant difference in energy cost, comfort or ease of use. Scott et al (2000) found the AMA to have higher interface pressures than the PPAM aid. There is however no known published evidence on whether an articulated EWA improves active knee control following prosthetic delivery and therefore shortens rehabilitation time. In addition there is no known published evidence of the effect on quality of life with the two different EWA's.
Hypothesis: An articulated Early walking aid has benefit to the transtibial amputee compared to a non- articulated EWA.
The purpose of this proposed research is to investigate whether there are any benefits to patients in using an articulated EWA.
The study will use EMG and gait analysis to determine the potential of each of the two EWA's to re-educate gait in a way that is comparable with the gait exhibited when the subject subsequently begins to use a prosthesis thus shortening rehabilitation time. Quality of life indicators will be used to determine the impact on the patient and, in addition, the length of time taken to full rehabilitation will be considered.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPAM Aid | Active comparator | Device: EWASuitable participants randomised to the treatment arm will receive the non articulated pneumatic early walking aid and rehabilitation physiotherapy will be commenced immediately. Physiotherapy will continue after they receive their definitive prosthesis till they are comfortable and safe using it, at which stage they will be discharged and no further follow up will be performed. |
| AMA Aid | Active comparator | Device: EWASuitable participants randomised to the treatment arm will receive the articulated early walking aid and rehabilitation physiotherapy will be commenced immediately. Physiotherapy will continue after they receive their definitive prosthesis till they are comfortable and safe using it, at which stage they will be discharged and no further follow up will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Have had a unilateral transtibial amputation but not yet received a prosthesis
- Are expected to receive a functional prosthesis
- Are at least 18 years of age
- Are able to tolerate and use an early walking aid
- Are able to be able to walk a distance of 4 metres
Key exclusion criteria (7 listed)
- Have had a major amputation of the contra lateral limb.
- Are not expected to receive a functional prosthesis
- Were unable to walk, prior to their amputation, due to a medical condition e.g. spinal injury, stroke or rheumatoid arthritis
- Are unable to follow instructions and/or participate in a programme of rehabilitation.
- Do not consent to participate in the study.
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 |
|---|---|---|
| EWAAlso: Pneumatic Post Amputation Mobility Aid - Ortho Europe Ltd,UK, Amputee Mobility Aid - Ortho Europe Ltd,UKSuitable participants randomised to the treatment arm to receive early walking aid and rehabilitation physiotherapy will be commenced immediately. Physiotherapy will continue after they receive their definitive prosthesis till they are comfortable and safe using it, at which stage they will be discharged and no further follow up will be performed. | Device | AMA Aid, PPAM Aid |
Primary outcome
Kinetic and kinematic comparison of the influence of 2 different EWAs on the transfer to prosthetic rehabilitation.
Time frame: Outcomes will be measured at baseline, time of EWA fitting, prosthesis fitting, 2 week post prosthesis fitting &on discharge from physiotherapy ensuring safe prosthesis use. Final visit will vary with each patient and will be analysed with outcomes.
1 secondary outcome
Quality of life measurements
Time frame: Outcomes will be measured at baseline, time of EWA fitting, prosthesis fitting, 2 week post prosthesis fitting &on discharge from physiotherapy ensuring safe prosthesis use. Final visit will vary with each patient and will be analysed with outcomes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2009.
- Background: PubMed 19367517Barnett C, Vanicek N, Polman R, Hancock A, Brown B, Smith L, Chetter I. Kinematic gait adaptations in unilateral transtibial amputees during rehabilitation. Prosthet Orthot Int. 2009 Jun;33(2):135-47. doi: 10.1080/03093640902751762.
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.
Amanda Hancock, MSc principal investigator
Department of Physiotherapy, Hull & East Yorkshire Hospitals NHS Trust
Ian C Chetter, MB ChB, FRCS study director
University of Hull
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EWA in people with Unilateral Trans-tibial Amputees, run by University of Hull at 3 sites in United Kingdom.
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 8 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 2 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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?
Results are not available in the source record.
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?
Kinetic and kinematic comparison of the influence of 2 different EWAs on the transfer to prosthetic rehabilitation. (time frame: Outcomes will be measured at baseline, time of EWA fitting, prosthesis fitting, 2 week post prosthesis fitting &on discharge from physiotherapy ensuring safe prosthesis use. Final visit will vary with each patient and will be analysed with outcomes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01024023, which also lists 1 linked publication.
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 2 Dec 2009.