DKS 2465: 2013  
© KEBS 2013 — All rights reserved  ii 
 
 
 
 
Orthoses — Upper limb Orthoses — 
Specification 
 
 
 
  
  
 
    
 
 
 KS 2465: 2013  
ii         © KEBS 2013 — All rights reserved  
TECHNICAL COMMITTEE REPRESENTATION 
 
The following organizations were represented on the Technical Committee: 
 Association for the Physically Disabled of Kenya 
Kenyatta University  
Ministry of Medical Services (MOMS) – Orthopaedic Technology Ministry of Medical Services (MOMS) – Occupational Therapy 
National Council of Persons with Disabilities (NCPWD) 
Kenya Medical Training College (KMTC) 
Kenya Society of Physiotherapist Kenyatta National Hospital 
National Association for Orthopaedic Technologist in Kenya (NAOT(K)) 
Isole Engineering Works Ministry of Nairobi Metropolitan Development 
Kenya Bureau of Standards – Secretariat 
 
 
 
 
  
 
 
 
 
 
 
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for improvements to published standards, addressed to the Managing Director, Kenya Bureau of Standards, 
are welcome.  
 
 
  
 
 
 
© Kenya Bureau of Standards, 2009 
 
Copyright.  Users are   reminded that by virtue of Section 25 of the Copyright Act, Cap. 12 of 2001 of the Laws of Kenya, copyr ight 
subsists in all Kenya Standards and except as provided under Section 26 of this Act, no Kenya Standard produced by Kenya Bureau  of 
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 DRAFT KENYA STANDARD        KS 2465: 2013  
ICS ……………..  
1. iii 
    
 
  
 
 
 
   
 
 
Orthoses — Upper limb Orthoses — 
Specification 
 
  
  
  
 
  
 
 
  
 
  
 
 
  
 
  
 
  
 
  
  
KENYA BUREAU OF STANDARDS (KEBS) 
 
Head  Office:  P.O. Box 54974, Nairobi-00200, Tel.: (+254  020) 605490, 602350, Fax: (+254 020)  604031 
E-Mail: info@kebs.org,  Web:http://www.kebs.org   
 
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© iv | Page KEBS 2013 — All rights reserved  iv    
 
 
FOREWORD 
 
This Kenya Standard has been prepared by the KEBS/TC 132 Assistive Products for persons with 
Disabilities Technical Committee and it is in accordance with the procedures of the Bureau.  
The Standard was found necessary in ensuring the quality of orthoses either manufactured locally or 
imported into this country. This is only a guide to the manufacturers, fabricators, service providers and users of orthoses. 
 
Orthoses are orthopaedic devices designed and basically used to support, correct, accommodate, prevent further deformity and facilitate movement to an injured or weakened limb, i.e, shoulder, elbow, arm, wrist or 
hand.  They can be useful for chronic conditions, acute injury, prevent scarring and formation of deformity, 
pain relieve and enhance joint function.   
The purpose of orthoses is to stabilize and immobilize t he upper limb, prevention or correction of the joint 
contractures and formation of burn scar tissue. Orthoses will also promote healing, assist joint movement and reduce muscle spasticity.  
In the preparation of this standard, reference was made to the following document: Upper-
Limb Orthotics, which we acknowledge:-  
a) Resting hand splint – Medical Center Brace, Pittsburgh, PA, 
b) 4 REHAB 442: Kinesiology and Biomechanics, Brian J. Dudgeon, Ph.D., OTR 
42: Kinesiology.  
Biomechanics 
Brian J. Dudgeon, Ph.D., OTR  
 
 
 
 
 
  
 
    
 
 
 
  
 
  
 
 
 
  
1. v 
  
DRAFT KENYA STANDARD 
Orthoses — Upper limb Orthoses — Specification 
 
 
10. SCOPE 
 
This standard covers the requirements pertaining  to medical and biomechanical principles, 
materials, shape, dimensions, workmanship, finish, fitting, use and performance of 
orthoses 
 
Application: Upper limb orthoses are used frequently on patients who have had 
neurological and neuromuscular problems, musc ulo – skeletal disorders such as stroke, 
traumatic brain injury (TBI), multiple sclerosis (MS), cerebral palsy (CP), spinal cord injury 
(SCI), muscle weaknesses and peripheral nerve injury.   
Note 1 : Orthoses shall be provided on a prescription. 
Note 2 : Placement may be dorsal, volar, or circumferential and extends from the tips of the fingers to cover 
two thirds of the distal forearm. The dorsal type of splint is particularly useful in patients who demonstrate 
palmar hypersensitivity and grasp reflex. 
 
2. REFERENCES 
 2.1 Resting hand splint – Medical Center Brace, Pittsburgh, PA.  2.2 4 REHAB 442: Kinesiology and Biomechanics, Brian J. Dudgeon, Ph.D., OTR 
42: Kinesiology 
 
3. TERMINOLOGY  For the purpose of this Kenya standard the following terms and definitions given in ISO 9999 shall apply:- 
3.1 Orthosis –  an orthopaedic device designed to support, correct, compensate, 
accommodate, prevent further deformity and aid movement to  an injured or weakened limb 
or spine. Orthoses can be useful for chronic conditions, acute injury and injury prevention. 
Orthoses are a non-surgical, removable and relatively cost effective treatment for many joint and muscular conditions . 
Note : Different areas are considered in orthotic management such as materials engineering, gait and activity of daily 
living analysis, body structure and functions, abnormal functions, application of forces and body’s reaction to the forces, 
and behaviour.  
3.2 Upper Limb Orthoses – are devices applied externally to restore and/or improve 
functional and structural characteristics of the muscles, skeleton and nervous systems. In 
general, conditions include those resulting from trauma, sports, and work-related injuries. 
(See the images below) 
3.3 Palmar (volar) – front of the hand  
© vi | Page KEBS 2013 — All rights reserved  iv 3.4  Dorsal – back of the hand 
3.5 Dorsiflexion  – wrist extension 
3.6 Metacarpophalangial (MP)  – joint between metacarpal bone and proximal phalange 
3.7 Forearm/wrist  orthoses  – devices used for immobilization and correction in patients 
with arthritis, spasm, wrist or forear m fracture, post operative wrist fusions, 
contractures and arthritic conditions. 
3.8 Thumb spica splints  – device that covers 2
/3 of the distal radial forearm up to the 
interphalangeal joint (IP). 
3.9  Interphalangeal joint  – joint between the phalanges. 
3.10 Dynamic orthoses  – orthosis that allow mobility. 
3.11 Static orthoses  – orthosis that do not mobility.  
10. MATERIALS 
 Orthoses can be constructed of plaster, wood,  leather, metal, cloth, or plastic. Most 
orthoses shall employ lightweight thermoplastic materials. The thermoplastic sheets shall 
be molded to fit body parts exactly, and some shall be reshaped repeatedly as the treated 
body part changes shape.  
 
4.1 The material used in the manufacture of orthotic devices shall be low-temperature 
thermoplastics and thermosetting that can be custom-made, prefabricated or moulded to 
fit. The material used shall be durable, tough, non-reactive to the skin, cosmetic and light weight.  
 
NOTE: High-temperature thermoplastic materials shall be  molded over a plaster model of the body part at a 
temperature that is too high to come in contact with human skin, but they have the advantage of being stronger and more durable than low-temperature thermoplastics. They are used in situations where the 
orthosis will under-go a lot of stress or will be used for a long time. 
 
4.2 Other materials shall include fasteners, fabric, adhesives and Velcro but shall meet 
the requirements of 4.1.  
 4.3 Custom-made orthoses may be fabricated by orthopaedic technologist or 
occupational therapists for hand splints. 
 
 
5. CLASSIFICATION, TYPES/CATEGORIES, SHAPE AND DIMENSIONS 
 
The classification, type/categories, shape and dimensions of the orthoses shall conform to 
the body contours based on the treatment plan.  
 
5.1 Classification  
 
Orthoses are classified into two; Static and dynamic (functional) orthoses. 
 
 Static orthoses do not allow motion; serve as rigid support in fractures, 
inflammatory conditions of tendons and soft tissue and nerve injuries.   
1. vii 
 5.1.2 Dynamic/functional orthoses-these devices do permit motion of the joints on which 
its own effectiveness depends.    
5.2 Types/Categories 
 
The types/categories of upper limb orthos es used shall consists of the following:- 
5.2.1 Upper arm orthoses 
These shall include the following:- a. Clavicular (collar bone) and shoulder orthoses  
b. Elbow orthoses as illustrated in Fig. 1 
c. Shoulder abductor and adductor orthoses as illustrated in Fig. 2. 
  
 
 
Fig. 1. Elbow orthoses  
© viii | Page KEBS 2013 — All rights reserved  iv 
 
Fig. 2 Shoulder adductor splint 
 
 Forearm –wrist orthoses  
 Forearm/wrist orthoses are palmar (volar) or dorsal and either gutter-based or 
circumferential.   Ideally, the wrist should be positioned in 15
o – 30o of dorsiflexion (wrist 
extension) except in carpal tunnel syndrome (CTS), when the wrist should be maintained at neutral to minimize median nerve compression.  These shall include the following:- 
a. The volar type should allow for metacarpophalangial (MP) joint flexion by ending 
before the distal palmar crease. 
b. Forearm – wrist orthoses  
These shall include the following: 
‐ Wrist cock-up splints 
‐ Wrist extension splints 
‐ Ulnar gutter splint  
1. ix 
 
 
Fig 3. Wrist cock-up splint 
 
‐ Hand resting splint as illustrated in Fig.3. 
 FOREARM –WRIST –THUMB ORTHOSES 
 
The types of the forearm – wrist –thumb orthoses include the following:- 
a. Thumb spica (abductor) splints as illustrated in Fig. 4 
 
Fig. 4. Thumb spica (abductor) splints 
 
b. Trigger splints as illustrated in Fig. 5 
 
 
 
Fig. 5. Trigger splints  
© x | Page KEBS 2013 — All rights reserved  iv  
 
 
c. Finger splint as illustrated in Fig. 6. 
 
 
 
 
 
Fig 6. Finger splint 
 
5.2.4 Forearm-Wrist-Hand Orthoses 
The basic types of forearm-wrist-hand orthoses shall include the following:- 
a. the hand resting splint as illustrated in Fig. 7 
 
Fig. 7. Hand resting splint 
b. the functional resting splint,  
c. the static hand splint.  
d. the burn splint  
e. the weight-bearing splint. 
5.2.5 Hand Orthoses 
Hand orthoses are categorized into two; static orthoses and dynamic orthoses 
 5.2.5.1 Static hand orthoses   
 Static hand orthoses is an orthoses that  do allow movement within the joints. 
 
5.2.5.2  Dynamic orthoses 
Dynamic  hand orthoses is an orthosis that  allows movement of the joint.  
 
 
 
10. Shape and Dimensions   
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This shall conform to client’s body size, contours and meeting the prescription 
cretiria.  
 
10. WORKMANSHIP AND FINISH 
The orthoses shall be fabricated from plaster of Paris bandages, fabric, metal and 
plastics. The orthoses shall be user friendly, cosmetically appropriate and shall 
meet the client’s/user’s requirement.  
7.1 Plastics 
Many upper limb orthoses are constructed of low-temperature thermoplastics. This 
material becomes pliable below 180°F (80°C), and it can be molded directly against 
the body. This material shall have excellent Ventilation, lightweight, durable, Non-
toxic, X-Ray translucent, Biodegradable, Self Bonding, Water resistant and easy to process. The material shall be in a variety of widths, thickness and color and can be 
padded to cushion sensitive areas.  
7.2 Plaster Of Paris bandages 
 
Plaster bandages consists of a cotton bandage that has been impregnated with 
plaster of Paris, which hardens after it has been made wet. Plaster of Paris is 
calcined gypsum, ground to a fine powder by milling. When water is added, the more soluble form of calcium sulphate returns to the relatively insoluble form and 
heat is produced. 
 
Plaster of Paris shall be easy to mould with water and setting time shall be 3 – 10 
minutes at 23 degrees centigrade. The  mould should be hard and lightweight, 
durable, and readily adjustable. On setting it takes a shape impression and 
comfortable fit.  
 
7.3 Fabric   
 
Fabrics are woven material that are soft, drapeable, strong and durable, resistant to 
shrinking and breathes well.  Fabrics shall be washable, easy to clean and dries 
quickly, non-toxic, non reactive and cosmetically acceptable. 
 
7.4 Metal   
 
The most commonly used metal is aluminium sheet. It is non corrosive, light weight, 
ductile, malleable, tough, impermeable, odourless and recyclable. The material shall be cosmetically acceptable, ease of fabrication, high strength to weight ratio and high fracture 
toughness. 
   
© xii | Page KEBS 2013 — All rights reserved  iv Note: Clients/users  often  use a separate interface that absorbs perspiration and protects the skin, 
and which can be washed or replaced as needed. Most modern orthoses use straps made of hook-
and-loop tape for this purpose.  
 
8. Criteria performance of materials 
 It is important that when fabricating orthos es using the materials described above, they 
should meet the minimum requirements and specifications by the manufacturer.  
 Note: The manufacturer should state the specifications of the materials used for fabricating 
orthoses as described above. 
 
9. MARKING  
9.1 Each pre-fabricated orthosis shall be permanently and indelibly marked with the 
manufacturer’s name, initials or recognized trade-mark and the size. 
 
10. PACKAGING  
10.1 Each pre-fabricated orthosis shall be supplied with a user manual 
 
10.2 Custom made orthoses shall have clear instructions to the user / client regarding the use and maintenance.  
 
 
  
1. xiii 
  
ANNEX A 
 
User Manual for Upper limb Orthosis 
 
Weakness of the upper limb can affect the way your body moves. An upper limb orthosis will help support, correct, and 
prevent further deformity. 
Instructions 
Things You’ll Need 
 Upper limb Orthoses 
1. Ask your doctor or physical/occupational therapist/orthopaedic technologist   to evaluate the strength of 
your upper limb. If an orthosis is needed, have a written prescription. Take your prescription to an 
orthopaedic technologist /orthotist (a person who makes orthosis). 
2. Slip or fit the orthosis on affected part of the arm. 
3. Use the Velcro strap to position and fasten the orthosis as shown and trained by the service provider.  
4. The service provider should train you on how to use and take care of the orthosis 
5. Visit your orthopaedic technologist/orthotist for any adjustments until you have a proper fit. Expect to 
feel some discomfort at first. 
6. Prevent skin problems from occurring with your new orthosis by following a “wearing” schedule. Wear 
your orthosis as recommended by the service provider. 
7. Always check affected body part for any areas of redness or change of skin colour, blisters or 
swellings, when you remove your orthosis. 
8. Notify your orthopaedic technologist/orthotist or doctor immediately if redness or change of skin colour 
occurs.  
9. Adjust your orthosis by loosening the Velcro straps if you notice redness or feel uncomfortable but ensure that it is well secured. 
10. Tips & Warnings 
 Orthosis are custom-made or off-the-shelf (prefabricated). The off-the-shelf (prefabricated) Orthosis will 
have to be adjusted to fit. 
 Do not soak in water. Keep orthosis clean by wiping with clean damp piece of clothing.  
 Always keep orthosis/ joints lubricated or well oiled 
 Keep the orthosis away from fire. 
 In case of wear and tear or damage, take the orthosis to the service provider for repair/ replacement. 
If you have any questions or concerns, contact a physician or other health care professional before engaging in any 
activity related to health and diet. This information is not intended as a substitute for professional medical advice or 
treatment.  
© xiv | Page KEBS 2013 — All rights reserved  iv FORM: STA/SD/OP/03/F3 
 
COMMENTS FORM 
 
Title:  DKS 2465  DRAFT Kenya Standard – Orthoses — Upper limb Orthoses   – 
Specification  
Document Type: Public review comments 
KEBS/TC 132  Assistive Produc ts for for Persons with Disabilities
Dates: Circulation date Closing date:  
: 2013-03-08 2013-05-08 
Recipient This form is to be filled, signed and returned to Kenya Bureau of Standards 
for the attention of Chomu Miheso  email: chomumc@kebs.org
 
 
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