WeaknessPhase 3FAMENCT00666744
A Randomised Controlled Trial of Family Mediated Exercises (FAME) Following Stroke
A Phase 3 study testing Family Mediated Exercise Therapy in people with Weakness and Balance, run by University of Dublin, Trinity College at 2 sites in Ireland.
Trial summary
The aim of the study is to evaluate the functional recovery in two groups of primary stroke patients presenting with moderate/severe disability over a six month period through the implementation of a randomised controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Family Mediated Exercise Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesIreland
- Study dates
- Apr 2008to Mar 2009
- Phase
- Phase 3
- 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
- diagnosis of first unilateral stroke
- Patients who score between 3.2 and 5.2 on the Orpington Prognostic Scale
- Patients participating in a physiotherapy programme
- Patients willing to give informed written consent
- Patients with family willing to participate in their assigned physiotherapy intervention programme
Who cannot join
- hemiplegia of a non-vascular origin
- discharged from hospital less than two weeks following stroke
- pre-existing neurological disorder
- any lower limb orthopaedic condition that may limit exercise capacity
- aphasia
- cognitive impairment
- not willing to give written consent
Trial locations and contacts
2 sites in 1 country.
Ireland2 sites, 2 recruiting
- Recruiting
Beaumont Hospital
Dublin
Julie Shanahan, BSc, 00 353 1 809 2535, julieshanahan@beaumont.ie
Julie Shanahan, BSc
- Recruiting
MaterMisercordiae University Hospital
Dublin
Orla Friel, BSc, 00 353 1 8034273, physiorehab@mater.ie
Orla Friel, BSc
About this study
The aim of the study is to evaluate the functional recovery in two groups of primary stroke patients presenting with moderate/severe disability over a six month period through the implementation of a randomised controlled trial. The first group or the experimental group will receive routine therapy and additional lower limb exercise therapy in the form of family assisted exercises. The second group or the control group will receive routine therapy with no additional formal input from their family members. A secondary aim of the project is to evaluate the impact of the FAME programme on the person with stroke and the individual (s) assisting in the delivery of exercises.
Read the detailed description
Participants with primary stroke eligible for inclusion to the study at 2 weeks post stroke will be randomised into either a 'control' group that will receive routine therapy or an 'experimental' group that will receive routine therapy AND additional 'family mediated exercise therapy.
Training will be provided to the nominated family member (s)/friends of participants in the 'intervention' group on a weekly basis by the research physiotherapist (R1). Family members/friends will be requested to keep an exercise diary on a daily basis to document completion of exercises. The trial will continue for eight weeks with an expectation that at least 1200 additional minutes of FAME therapy will be delivered over this time period. Each FAME session is expected to last 35-40 minutes.
Exercises will include repetitive sit to stand exercises with an emphasis on improving symmetry, weight bearing exercises during standing, bridging, straight leg raises, quadriceps strengthening exercises, active/active assisted range of movement exercises for the lower limb and walking. Outcome will be assessed by a blinded outcome assessor (R2) on entry to the study, at eight weeks (post-intervention) and again three months post-intervention (follow-up)
In addition, a semi-structured interview will be carried out with a random sample of the participants and their family member (s)/friends to gain a more qualitative insight into the impact of the programme on those involved. This interview will be completed by a person unknown to the participant. (R3)
- Being tested
- Family Mediated Exercise Therapy
- Keywords
- exercise, frequency, duration
- Medical subject headings
- Asthenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Mediated Exercise TherapyOther
35 minutes of lower limb exercises to be completed by the person with stroke on a daily basis with the assistance of their family for a period of 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Exercise Intervention - additional lower limb exercises will be completed by the person with stroke with the assistance of his/her family for 35 minutes daily for a period of 8 weeks. Receives: Other: Family Mediated Exercise Therapy |
| 2 | No intervention | Participants in this group will receive routine exercise therapy following stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl Meyer (FM) Assessment
Measured: Baseline, post intervention and 3 month follow-up
Secondary outcomes (6)
Berg Balance Scale (BBS)
Measured: Baseline, post intervention and 3 month follow-up
Motor Assessment Scale (MAS)
Measured: Baseline, post-intervention and 3 month follow up
Six Minute Walk Test (SMWT)
Measured: Baseline, post-intervention and 3 month follow up
Barthel Index (BI)
Measured: Baseline, post-intervention and 3 month follow up
Re-integration into Normal Living Index (RNLI)
Measured: Baseline, post-intervention and 3 month follow up
Nottingham Extended Activities of Daily Living (EADL)
Measured: Baseline, post-intervention and 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionMar 2009 (estimated)
- Study completionMar 2009 (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 WeaknessStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Medical Research, Friends of the Royal Hospital Donnybrook
- Investigators
- Emma Stokes, PhD, Principal investigator, University of Dublin, Trinity CollegeTara Cusack, PhD, Principal investigator, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666744
- Sponsor's protocol ID
- 08/19
- Other IDs
- Irish Heart Foundation - FAME
- Acronym
- FAME
- Status last verified
- Apr 2008
- First submitted
- 23 Apr 2008
- Last updated
- 29 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Galvin R, Cusack T, Stokes E. A randomised controlled trial evaluating family mediated exercise (FAME) therapy following stroke. BMC Neurol. 2008 Jun 20;8:22. doi: 10.1186/1471-2377-8-22.
PubMed 18570643
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Family Mediated Exercises (FAME) Following Stroke
- ClinicalTrials.gov ID
- NCT00666744
- Acronym / sponsor ID
- FAME / 08/19
- Keywords
- exercise, frequency, duration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Collaborators
- Foundation for Medical Research, Friends of the Royal Hospital Donnybrook
- Study start
- Apr 2008
- Primary completion
- Mar 2009 (estimated)
- Study completion
- Mar 2009 (estimated)
- First posted
- 25 Apr 2008 (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.
The aim of the study is to evaluate the functional recovery in two groups of primary stroke patients presenting with moderate/severe disability over a six month period through the implementation of a randomised controlled trial. The first group or the experimental group will receive routine therapy and additional lower limb exercise therapy in the form of family assisted exercises. The second group or the control group will receive routine therapy with no additional formal input from their family members. A secondary aim of the project is to evaluate the impact of the FAME programme on the person with stroke and the individual (s) assisting in the delivery of exercises.
Detailed description
Participants with primary stroke eligible for inclusion to the study at 2 weeks post stroke will be randomised into either a 'control' group that will receive routine therapy or an 'experimental' group that will receive routine therapy AND additional 'family mediated exercise therapy.
Training will be provided to the nominated family member (s)/friends of participants in the 'intervention' group on a weekly basis by the research physiotherapist (R1). Family members/friends will be requested to keep an exercise diary on a daily basis to document completion of exercises. The trial will continue for eight weeks with an expectation that at least 1200 additional minutes of FAME therapy will be delivered over this time period. Each FAME session is expected to last 35-40 minutes.
Exercises will include repetitive sit to stand exercises with an emphasis on improving symmetry, weight bearing exercises during standing, bridging, straight leg raises, quadriceps strengthening exercises, active/active assisted range of movement exercises for the lower limb and walking. Outcome will be assessed by a blinded outcome assessor (R2) on entry to the study, at eight weeks (post-intervention) and again three months post-intervention (follow-up)
In addition, a semi-structured interview will be carried out with a random sample of the participants and their family member (s)/friends to gain a more qualitative insight into the impact of the programme on those involved. This interview will be completed by a person unknown to the participant. (R3)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Family Mediated Exercise TherapyExercise Intervention - additional lower limb exercises will be completed by the person with stroke with the assistance of his/her family for 35 minutes daily for a period of 8 weeks. |
| 2 | No intervention | –Participants in this group will receive routine exercise therapy following stroke |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- diagnosis of first unilateral stroke
- Patients who score between 3.2 and 5.2 on the Orpington Prognostic Scale
- Patients participating in a physiotherapy programme
- Patients willing to give informed written consent
- Patients with family willing to participate in their assigned physiotherapy intervention programme
Key exclusion criteria (7 listed)
- hemiplegia of a non-vascular origin
- discharged from hospital less than two weeks following stroke
- pre-existing neurological disorder
- any lower limb orthopaedic condition that may limit exercise capacity
- aphasia
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 |
|---|---|---|
| Family Mediated Exercise Therapy35 minutes of lower limb exercises to be completed by the person with stroke on a daily basis with the assistance of their family for a period of 8 weeks. | Other | 1 |
Primary outcome
Fugl Meyer (FM) Assessment
Time frame: Baseline, post intervention and 3 month follow-up
6 secondary outcomes
Berg Balance Scale (BBS)
Time frame: Baseline, post intervention and 3 month follow-up
Motor Assessment Scale (MAS)
Time frame: Baseline, post-intervention and 3 month follow up
Six Minute Walk Test (SMWT)
Time frame: Baseline, post-intervention and 3 month follow up
Barthel Index (BI)
Time frame: Baseline, post-intervention and 3 month follow up
Re-integration into Normal Living Index (RNLI)
Time frame: Baseline, post-intervention and 3 month follow up
Nottingham Extended Activities of Daily Living (EADL)
Time frame: Baseline, post-intervention and 3 month follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2008.
- Derived from this study: PubMed 18570643Galvin R, Cusack T, Stokes E. A randomised controlled trial evaluating family mediated exercise (FAME) therapy following stroke. BMC Neurol. 2008 Jun 20;8:22. doi: 10.1186/1471-2377-8-22.
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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.
Emma Stokes, PhD principal investigator
University of Dublin, Trinity College
Tara Cusack, PhD principal investigator
University College Dublin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Family Mediated Exercise Therapy in people with Weakness and Balance, run by University of Dublin, Trinity College at 2 sites in Ireland.
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 5 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 29 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Emma K Stokes, PhD (00 353 1 896 2127, estokes@tcd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl Meyer (FM) Assessment (time frame: Baseline, post intervention and 3 month follow-up). 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 NCT00666744, 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 29 Oct 2008.