Research proposal

Impacts of Ankle Foot Orthoses on Quality of

Life to Poststroke Hemiparetic Patients in
Kilimanjaro-Tanzania.

Student’s No: Cgb20188

OVERVIEW OF THE
PRESENTATION
Introduction Objectives

Statement of problem Methodology

Justification of the study Time Frame

Literature Review Budget

Research Question References

STUDENT'S NO; CGB20188 MODULE NAME: RESEARCH METHODOLOGY CODE; 94938 2
LIST OF ABREVIATION
AFO; Ankle-Foot Orthoses
DAFO; Dynamic Ankle Foot Orthoses
PLS-AFO; Posterior Leaf Spring Ankle Foot Orthosis
MOS SF-36; Medical Outcome Study Short-Form-36
QoL; Quality of Life
HRQoL; Health Related Quality of Life
MWT; Minute Walk Test
KCMC; Kilimanjaro Christian Medical University College
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Introduction
Stroke

Incidence in Tanzania; 109 to 316 strokes per 100,000

persons annually (Hertz et al., 2019a).

Kilimanjaro region incidents; 3 admissions in 1974-1976 to

407 admissions in 2017-2018 at KCMC (Hertz et al., 2019b).

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Introduction
Stroke is associated hemiparesis.

Hemiparesis is a muscular weakness (Bindawas et al., 2017).

Limit activities of daily living, reduces QoL, cause

depression and poor inclusion and participation.

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Introduction
Poststroke hemiparetic patients have difficult in coordinating
movement.

60% of patients can conduct simple activities of daily living after

inpatient rehabilitation of at least a 6 month (Dobkin, 2004).

Rehabilitation improve patients walking ability and reduce risks

of falls.

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Introduction
Gait deviations; reduced hip and knee flexion, and reduced
dorsiflexion, which leads to insufficient toe clearance
(Pongpipatpaiboon et al., 2018).

Use of AFO is a priority in clinical improvement poststroke

(Bowers and Ross, 2010).

AFOs improve balance and gait.

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Problem statement
A study on QoL poststroke showed improvement on
functional outcomes through physical and occupational
therapy rehabilitation service (Howitt et al., 2011).

No study on effect of Orthotic management on QoL.

This study will investigate effects of AFO on QoL.

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Justification of the study
Focus is on effects of AFO on temporospatial parameters,
and not on QoL (McMonagle, Rasmussen, & Elliott, 2009).

Measuring QoL helps understand patients' reactions towards

their condition and effectiveness of care (Gupta et al., 2008).

This study will show importance of AFO on QoL for

poststroke hemiparetic patients.

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Literature review
1st iteration; Peer reviewed journals (Medline, google
scholar and PubMed).
2nd iteration; general internet search.
Not limited to year of publication but English language.
Keywords; Ankle foot orthoses AND QoL AND Stroke.

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 QoL during and after stroke rehabilitation

Sample
Author Study design Aim Results Conclusion
size
Hopman prospective 25 Assess HRQoL Improved 8 HRQoL domains HRQoL during inpatient
and study changes during of the MOS SF-36 during rehabilitation may change
Verner inpatient inpatient rehabilitation, but after discharge, therefore
(2003) rehabilitation only 3 domains continued need for continuous
and 6-months improving after discharge. support and service for
after discharge poststroke patients.

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 Effects of AFO designs on hemiparesis patients

Sample
Author Study design Aim Results Conclusion
size
Cakar cross-over 25 Investigate effects of PLS- The Berge score PLS-AFO reduced a
et al. interventional AFO on balance and fall increased with AFO use risk of falls and
(2010) study risks of post-stroke and the overall stability improved balance
hemiparesis ambulators score improved with
AFO use

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 Effects of AFO designs on hemiparesis patients
Author Study design Sample Aim Results Conclusion
size
Erel et al. Randomized 28 Investigation of short Initially there was no difference Patients with
(2011) controlled term and long-term between the control and study chronic
trial effects of DAFO on group, 3 months later, the hemiparesis may
ambulation in chronic study group , who were benefit from using
hemiparetic patients prescribed with DAFO showed DAFO
significant improvement in
ambulation time, and walking
velocity

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 Role of AFO on functional recovery in
hemiparesis patients
Author Study design Sample Aim Results Conclusion
size
Momosaki Retrospective 1863 Investigate functional 30.7% of 1863 patients AFO prescription
et al. cohort study recovery for post given AFO had higher scores depict better
(2015) stroke patients as a on Functional functional recovery
result of AFO use Independence Measures for stroke survivors,
following than those without AFO. hence a feasible
rehabilitation Also able to perform option for stroke
exercise independently rehabilitation
compared to the group improvement.
without AFO.

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 Role of AFO on functional recovery in
hemiparesis patients
Author Study design Sample Aim Results Conclusion
size
Sankaranarayan Prospective 26 To study the role Hemiparesis poststroke Gait parameters are
et al. (2016) rehabilitation of AFO in patient would walk 90 improved significantly
study locomotion and meters without AFO on with AFO when
functional recover admission in a 6MWT, combined with
poststroke at discharge, they activity-based
walked 174m with AFO, inpatient-
and 121m without AFO. rehabilitation

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Research question
What are the effects of AFO on QoL to poststroke hemiparetic
patients?

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Objectives of the study
Main objective
To investigate effects of AFO on QoL to poststroke hemiparetic
patients.

Specific objectives
Fabricate AFO for hemiparetic stroke patients.
Compare QoL when using AFO and when not using AFO.

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Methodology
Study design
A randomized crossover study design.

Study Area
Kilimanjaro region in Tanzania.

Sample population
Chronic hemiparetic poststroke patients who have completed
physiotherapy sessions.

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Methodology
Sample size
20 poststroke hemiparetic patients.

Sampling technique
A purposive sampling.

Data collection tool

MOS SF-36 questionnaire.
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Methodology
Method for data collection
Initially answering of MOS SF-36 questionnaire.
Participants allocation into 2 groups for 8 weeks, then fill in
questionnaire.
Washout period of 3 weeks.
Participants reverse groups.
AFOs fabrication.
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Methodology
Inclusion criteria
Chronic Poststroke hemiparetic patients.
Those have never used AFO.
Middle aged adults (40-60 years).
Independent community ambulators.

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Methodology
Exclusion criteria

Patients with severe hemiplegia.

Children, youth and elderly (> 60 years).

Cognitive impairment.

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Methodology
Data analysis

SPSS version 15.

Descriptive analysis computed using means, range and

standard deviations.

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 Ethical consideration
Written informed consent obtained from participants.
Ethical clearance
The University of Strathclyde Ethics Committee (UEC).
KCMC Research Committee.

Medical Research Coordinating Committee in Tanzania.

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Dissemination of results
Orthotic department, Physiotherapy and occupational
therapy departments at KCMC.

Published in peer reviewed journals.

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Outcome measures
All the domains in the MOS SF-36 tool.
Physical functioning
Social functioning
Role limitations due to physical problems
Role limitations due to emotional problems
General health
Mental health
Vitality
Bodily pain . Cech and Martin, 2012

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 Timeframe
Activity Feb- Jan-Aug 2022 Sept Oct 2022 Nov 2022 Dec 2022 Jan 2023 Feb 2023 March April May
April 2022 2023 2023 2023
2021
Proposal development                                                                                              
Ethical Clearance                                                                                              
Sample selection and Initial data collection (SF-36)                                                                                              
AFO Fabrication for group 1                                                                                              
Use of AFO for group 1 and nonuse of AFO for group 2                                                                                              
2nd Data collection (SF-36)                                                                                              
Washout period                                                                                              
AFO Fabrication for group 2                                                                                              
Use of AFO for group 2 and nonuse of AFO for group 1                                                                                              
Final data collection (SF-36)                                                                                              
Data analysis                                                                                              
Report compilation                                                                                              
Submission                                                                                              

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 Budget
ITEMS DESCRIPTION AMOUNT IN POUNDS
Stationaries Printing of questionnaires, photocopying, pens 200
Material for fabrication of AFO  Polypropylene plastic, POP bandage, POP 1000
powder, Velcro bands 
Statistician In data analysis and statistical assistance 150
Ethical clearance fee To be paid at KCMC and MRCC 400
Transport For follow-up of participants at their respective 500
  homes
Internet services   50
Miscellaneous Other forget necessary costs. 200
GRAND TOTAL   2500

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 References
Bindawas, S. M. et al. (2017) ‘Functional recovery differences after stroke rehabilitation in patients with uni- or bilateral hemiparesis’, Neurosciences
(Riyadh, Saudi Arabia), 22(3), pp.186–191.
Bowers, R. and Ross, K. (2010) 'Development of a Best Practice Statement on the Use of Ankle-Foot Orthoses Following Stroke in Scotland’, Prosthetics
and Orthotics International, 34 (3), pp. 245-253.

Cakar, E. et al. (2010) ‘The ankle-foot orthosis improves balance and reduces fall risk of chronic spastic hemiparetic patients’, Eur J Phys Rehabil Med,
46, pp.363-368

Cech, D.J. and Martin, S.T. (2012) 'Chapter 5 - Evaluation of Function, Activity, and Participation'. Functional Movement Development Across the Life
Span (Third Edition). Saint Louis: W.B. Saunders, pp. 88-104.

Dobkin B. H. (2004) ‘Strategies for stroke rehabilitation’, The Lancet. Neurology, 3(9), pp.528–536.

Erel, S. et al. (2011) ‘The effects of dynamic ankle-foot orthoses in chronic stroke patients at three-month follow-up: a randomized controlled trial’,
Clinical Rehabilitation, 25(6), pp.515–523.

Gupta, A. et al. (2008) ‘Quality of life and psychological problems in patients undergoing neurological rehabilitation’, Annals of Indian Academy of
Neurology, 11(4), pp.225–230.

Hertz, J.T. et al. (2019a) 'Perceptions of Stroke and Associated Health-Care-Seeking Behavior in Northern Tanzania: A Community-Based
Study'. Neuroepidemiology, 53 (1-2), pp. 41-47.

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 References
Hertz, J.T et al. (2019b) ‘The burden of acute coronary syndrome, heart failure, and stroke among emergency department admissions in
Tanzania: A retrospective observational study’, African journal of emergency medicine, 9(4), pp.180–184
Hopman, W.M. and Verner, J. (2003) ‘Quality of Life During and After Inpatient Stroke Rehabilitation’, Stroke, 34(3), pp 801-805.
Howitt, S.C. et al. (2011) ‘A cross-sectional study of quality of life in incident stroke survivors in rural northern Tanzania’, Journal of
Neurology, 258, pp.1422–1430.
McMonagle, C., Rasmussen, S., & Elliott, M. (2009). Relationship between use of ankle-foot orthoses and quality of life and psychological
well being: a research plan. Poster session presented at Psychology Research Day, Glasgow, UK, Available at;
https://pure.strath.ac.uk/ws/portalfiles/portal/65394916/strathprints016649.pdf (Accessed; 14 March 2020).
Sankaranarayan, H. et al. (2016) ‘Role of ankle foot orthosis in improving locomotion and functional recovery in patients with stroke: A
prospective rehabilitation study’, Journal of neurosciences in rural practice, 7(4), pp.544–549.
Momosaki, R. et al. (2015) ‘Effects of ankle-foot orthoses on functional recovery after stroke: a propensity score analysis based on Japan
rehabilitation database’. PloS one, 10(4), p.e0122688.
Pongpipatpaiboon, K et al. (2018) ‘The impact of ankle-foot orthoses on toe clearance strategy in hemiparetic gait: a cross-sectional
study’, Journal of neuroengineering and rehabilitation, 15(1), pp.41.

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