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T5-7V REPORT OF FIFTEENTH MEETING SUBCOMMITTEE ON EVALUATION COMMITTEE ON PROSTHETICS RESEARCH AND DEVELOPMENT DIVISION OF MEDICAL SCIENCESâNATIONAL RESEARCH COUNCIL NATIONAL ACADEMY OF SCIENCES-NATIONAL ACADEMY OF ENGINEERING Washington, D.C. A p r i l 9, 1973 Members Pre s e n t : Members Absent: Developers P r e s e n t : I n v i t e d P a r t i c i p a n t s Present: I n v i t e d P a r t i c i p a n t s Absent: S t a f f Members Pre s e n t : Frank W. C l i p p i n g e r , J r . , Chairman Arthur W. G u i l f o r d , J r . C h a r l e s W. R a d c l i f f e G. E. Sharpies James M. Morris Gustav Rubin W i l l i a m M. Bernstock F r e d e r i c k L. Hampton A l v i n L. Muilenburg S i e g f r i e d W. P a u l Edward P e i z e r Michael J . Quigley Anthony S t a r o s Howard R. Thranhardt B e r t R. T i t u s Joseph E. Traub Robert L. Romano Hector W. Kay Maurice A. LeBlanc John Lyman A. Bennett Wilson, J r . MAY 1 9 23C9 TOE GEORGE E. BROWN, JR. LIBRARY MAY I S Tffi GEORGE E.BROm JR. LIBRARY The main purpose of the meeting was to d i s c u s s p l a n s f o r the c l i n i c a l e v a l u a t i o n of two s p i n a l orthoses. The s t a t u s of ongoing p r o j e c t s and new items recommended f o r e v a l u a t i o n a l s o were d i s c u s s e d . Appendices A and B a r e the agenda and l i s t of p a r t i c i p a n t s r e s p e c t i v e l y . Planned C l i n i c a l E v a l u a t i o n of S p i n a l Orthoses Spinal Orthosis Dr. Rubin presented the VAPC "Lumbo-Sacral A-P and M-L C o n t r o l 1; O r t h o s i s I n c o r p o r a t i n g a Stimulus to Withdrawal" and distribute<|tfi«?ples MAY 21^973
2 Subcommittee on E v a l u a t i o n of the d r a f t f a b r i c a t i o n manual. The f o l l o w i n g a r t i c l e i s an e a r l y r e p o r t on t h i s o r t h o s i s : "A Spring-Loaded Low Back Brace," Gustav Rubin, M.D., F.A.C.S. and Werner Greenbaum, C.P.O., B u l l e t i n of P r o s - t h e t i c s Research, BPRlO-15, Spring 1971. The o r t h o s i s i s f o r p a t i e n t s w i t h c h r o n i c low-back-pain, and i s now being made w i t h p r e f a b r i c a t e d p a r t s . About 15 p a t i e n t s have been f i t t e d to date. UCBL Spinal Orthosis Dr. Morris presented the new UCBL v e r s i o n of the " R o y a l i t e F l e x i o n J a c k e t " o r i g i n a l l y d e s c r i b e d i n the f o l l o w i n g a r t i c l e : "The R o y a l i t e F l e x i o n J a c k e t , " Frank L. Rainey, J r . , M.D., Report of a Workshop on S p i n a l O r t h o t i c s h e l d on March 28-29, 1969, and sponsored by the Committee on P r o s t h e t i c s Research and Development, N a t i o n a l Academy of S c i e n c e s . The o r t h o s i s has been renamed the "Laminated S e m i - F l e x i b l e Body J a c k e t w i t h I n f l a t a b l e Pads." I t i s f o r p a t i e n t s w i t h c h r o n i c low-back-pain, and i s made of laminated p o l y e s t e r p l a s t i c from a body c a s t of the p a t i e n t s as d e s c r i b e d i n the handout which i s i n c l u d e d as Appendix C. About 25 p a t i e n t s have been f i t t e d to date. Evaluation Protocol Mr. LeBlanc presented a d r a f t p r o t o c o l f o r the e v a l u a t i o n . I t was agreed that c e r t a i n changes should be made to the proposed plan, which i s i n c l u d e d as Appendix D. 1. P a t i e n t s w i t h r e c e n t s p i n a l f u s i o n s w i l l be excluded from the study. However, p a t i e n t s w i t h o l d s p i n a l f u s i o n s w i l l be i n c l u d e d . 2. I t i s important t h a t the p a t i e n t s be screened f o r any under- l y i n g f i n a n c i a l motives which might a f f e c t t h e i r response to treatment. Other than t h a t , however, i t s h a l l be l e f t to the d i s c r e t i o n of the c l i n i c team whether the p a t i e n t w i l l make an a c c e p t a b l e s u b j e c t f o r the study, i . e . , i t i s not n e c e s s a r y t h a t the p a t i e n t have a r e g u l a r job. 3. The e v a l u a t i o n forms were presented, d i s c u s s e d i n some d e t a i l , and approved s u b j e c t to minor r e v i s i o n s . The AAOS t e c h n i c a l a n a l y s i s form f o r the spine and Dr. Mooney's p a t i e n t response form w i l l be i n c l u d e d .
Subconunittee on E v a l u a t i o n 3 4. S i n c e the two orthoses are s i m i l a r i n p r e s c r i p t i o n c r i t e r i a , the same numbers and types of p a t i e n t s w i l l be f i t t e d i n the study. 5. The f o l l o w i n g four c l i n i c s w i l l be in v o l v e d i n the c l i n i c a l a p p l i c a t i o n s : New York U n i v e r s i t y - Dr. L u s s k i n and o r t h o t i s t Northwestern U n i v e r s i t y - Dr. Keagy and o r t h o t i s t Rancho - Dr. Mooney and o r t h o t i s t Columbus, Ohio - Mr. Rosenquist and p h y s i c i a n 6. As se p a r a t e s t u d i e s . Dr. looms i n Memphis, Tennessee, has agreed to i n c l u d e these two dev i c e s i n an X-ray a n a l y s i s of s p i n a l orthoses which he w i l l be conducting, and Dr. Markoff a t UCLA has agreed to con- duct a biomechanical a n a l y s i s of the two d e v i c e s . 7. The f i r s t week i n June 1973 seemed to be the b e s t time to plan f o r the O r i e n t a t i o n S e s s i o n a t VAPC i n New York. Current S t a t u s of Other E v a l u a t i o n s Medtronio/Ranaho Implantable FES Orthosis Mr. Wilson reported that the c l i n i c a l e v a l u a t i o n of the Medtronic/ Rancho implantable FES o r t h o s i s i s pr o g r e s s i n g w e l l . There a r e about 100 u n i t s a v a i l a b l e ; seven c l i n i c s a r e p a r t i c i p a t i n g ; and about 15 peroneal nerve s t i m u l a t o r s have been implanted to date. Patient Analysis and Rx Forms Mr. Kay reported t h a t the AAOS t e c h n i c a l a n a l y s i s forms, developed l a r g e l y through the e f f o r t s of Dr. McCollough i n Miami, are a v a i l a b l e f o r the lower limb and upper limb. Those f o r the s p i n e w i l l be a v a i l a b l e s h o r t l y . A l l the t e c h n i c a l a n a l y s i s forms now i n c l u d e a p r e s c r i p t i o n c h a r t w i t h the newly developed nomenclature. I t i s the hope th a t these forms w i l l provide good, p r o f e s s i o n a l communication between the p h y s i c i a n and o r t h o t i s t / p r o s t h e t i s t on the dy s f u n c t i o n of the p a t i e n t , r e s u l t i n g i n b e t t e r s e r v i c e . AFO Study at Moss Mr. Wilson reported t h a t Moss R e h a b i l i t a t i o n H o s p i t a l has com- pl e t e d the kinematic study of about 12 AFOs and i s now undertaking a dynamic study of the same d e v i c e s . I t i s an ongoing e f f o r t , and a r e p o r t of the kinematic phase w i l l be a v a i l a b l e soon. I t i s the hope t h a t t h i s p r o j e c t w i l l y i e l d information h e l p f u l f o r the c l i n i c a l s e l e c t i o n of AFOs.
Subcommittee on E v a l u a t i o n Comparison of ULOs Mr. LeBlanc reported t h a t there w i l l be a meeting on May 16-17, 1973, to d i s c u s s the three upper-limb o r t h o t i c systems which a r e a v a i l - a b l e commercially. (Conry/Snelson/Rancho system, Engen/TIRR system, and the Lehneis/IRM system.) The meeting to be c h a i r e d by Mr. Berger of NYU w i l l i n c l u d e the developers and the four u n i v e r s i t y - l e v e l o r t h o t i c - p r o s t h e t i c s c h o o l s . The purpose i s to s o r t out the r e l a t i v e advantages and disadvantages of each system so the s c h o o l s w i l l have b e t t e r guide- l i n e s f o r teaching, and c l i n i c i a n s f o r u s i n g i n p r a c t i c e . VA Evaluation of Externally Powered ULPs Mr. Bernstock and Dr. P e i z e r reported the p r e l i m i n a r y r e s u l t s of the above-mentioned study, which i n c l u d e s the VAPC s w i t c h - c o n t r o l l e d elbow, the VAPC s w i t c h - c o n t r o l l e d hand, and the NU-VAPC EMG-controlled hand as p a r t of the NU s e l f - c o n t a i n e d , s e l f - s u s p e n d e d , below-elbow p r o s t h e t i c system. While the r e s u l t s seemed g e n e r a l l y f a v o r a b l e , there was some d i s c u s s i o n about what f u t u r e a c t i o n s should be taken. F u r t h e r d i s c u s s i o n was postponed u n t i l the f i n a l r e s u l t s of the study a r e a v a i l a b l e . C o n s iderations f o r Future E v a l u a t i o n Items from 8th Workshop on LLO Mr. LeBlanc presented the items from the 8th Workshop on LLO which were recommended f o r e v a l u a t i o n . Each item was d i s c u s s e d , and the consensus was: 1. The Nitschke s i n g l e - b a r , Lehneis "SKA," and UCLA "FLLB" KAOs exemplify the need f o r some s o r t of study to p a r a l l e l the type of a n a l y s i s being done at Moss on AFOs. The U n i v e r s i t y of Washington was mentioned as a p o s s i b i l i t y f o r such a biomechanical a n a l y s i s to take p l a c e . 2. The s u c c e s s by C r a i g R e h a b i l i t a t i o n H o s p i t a l i n ambulating p a r a p l e g i c s was a t t r i b u t e d as much to t h e i r comprehensive approach as to the Bruce S c o t t orthoses being used. The VAPC volunteered to take a c l o s e r look to see what can be learned, e s p e c i a l l y w i t h regard to improving s e r v i c e a t the VA s p i n a l - c o r d i n j u r y c e n t e r s . 3. The p o l y c e n t r i c o r t h o t i c knee j o i n t developed by Mr. Long i n Denver has been purchased independently by s e v e r a l o r t h o t i s t s around
Subcommittee on E v a l u a t i o n the country. A f t e r some experience w i t h i t , these people w i l l be p o l l e d to get t h e i r r e a c t i o n s before making any recommendations or undertaking any formal e v a l u a t i o n . BKP Study at Ranaho Mr. Wilson presented a proposed study of two techniques for c a s t i n g and m o d i f i c a t i o n i n making below-knee p r o s t h e t i c s o c k e t s . T h i s study was recommended a t the r e c e n t Workshop on Above-Knee and Below- Knee P r o s t h e t i c s i n S e a t t l e on January 27-29, 1973. With minor changes the study was approved as o u t l i n e d i n Appendix E. Also, Duke U n i v e r s i t y expressed an i n t e r e s t i n p a r t i c i p a t i n g i f d e s i r e d . Vaouim Forming Techniques Mr. Wilson summarized the r e c e n t i n t e r e s t and a c t i v i t y i n vacuum-forming of th e r m o p l a s t i c m a t e r i a l s f o r o r t h o t i c and p r o s t h e t i c a p p l i c a t i o n s and made the f o l l o w i n g two recommendations: 1. That Moss R e h a b i l i t a t i o n H o s p i t a l , VAPC, and IRM combine e f f o r t s to t r y to e s t a b l i s h g u i d e l i n e s f o r f a b r i c a t i n g and f i t t i n g AFOs by r e l a t i n g f u n c t i o n a l requirements to the vacuum-forming pr o c e s s , i n c l u d i n g the t r i m and use of d i f f e r e n t t h e r m o p l a s t i c m a t e r i a l s . T h i s idea was accepted by those i n attendance, and CPRD s t a f f was given the charge of developing a plan to proceed by. 2. That a s m a l l workshop be h e l d of o r g a n i z a t i o n s which now have vacuum-forming machines and some experience w i t h them. The goal would be to b r i n g everyone up to date on the s t a t e of the a r t and to provide g u i d e l i n e s f o r others i n t e r e s t e d i n developing t h e i r own vacuum-forming c a p a b i ] i t i e s . This i d e a was favorably r e c e i v e d , and CPRD s t a f f w i l l take a c t i o n on i t . Items from 9th Workshop on ULP Mr. Kay presented the items from the above-mentioned workshop which were recommended f o r e v a l u a t i o n . Each item was d i s c u s s e d , and the f o l l o w i n g was decided: 1. The VAPC volunteered to purchase some of the Winnipeg cable-recovery u n i t s f o r f i t t i n g and e v a l u a t i o n on VA p a t i e n t s by Mr. Thranhardt i n A t l a n t a .
