Evaluation of a Spasticity Management Program for People With Multiple Sclerosis
Phase: NA
Conditions: Multiple Sclerosis
Sponsor: VA Office of Research and Development

Evaluation of a Spasticity 
Management Program for 
People with Multiple 
Sclerosis
NCT03166930
June 3, 2021

 
1 
 
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4 
 
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5 
 
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6 
 
 <Protocol version date:6/3/2021>  
 
Research Service Template: 9/9/15 
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7 
 
 <Protocol version date:6/3/2021>  
 
Research Service Template: 9/9/15 
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8 
 
 <Protocol version date:6/3/2021>  
 
Research Service Template: 9/9/15 
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QL@LJM>OBQEB?BKBCFQP>KAPFABBCCB@QPLCPQOBQ@EFKDQLLQEBOPM>PQF@FQVQOB>QJBKQPPR@E
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BS>IR>QBBCCB@QPLKJLO?FAFQV>KAJLOQ>IFQV>@QFSFQVM>OQF@FM>QFLK>KANR>IFQVLCIFCB'C
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FJMLOQ>KQQLQEB4PR@E>PQO>RJ>QF@?O>FKFKGROVPMFK>I@LOAFKGROV>KAPQOLHB


 
9 
 
 <Protocol version date:6/3/2021>  
 
Research Service Template: 9/9/15 
99:A,?4:9:1?30;=:;:>0/=0>0,=.3
*>@HLC>PQ>KA>OAFWBAMOLDO>JCLOPQOBQ@EFKDE>P?BBKLKBLCQEBJ>FKOB>PLKP
MOLDOBPPFK+1PM>PQF@FQVQOB>QJBKQE>P?BBKPQ>IIBACLOLSBOVB>OP5B
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PQ>KA>OAFWBAPQOBQ@EFKD@LJMLKBKQQE>QFPPRMMLOQBA?V>"4"ABJLKPQO>QFKDQEB
PQOBQ@EFKDBUBO@FPBP>KAJ>KR>IPTFQEMF@QROBP>KATOFQQBKABP@OFMQFLKPLCQEBPQOBQ@EBP
QE>QE>PFKFQF>IBCCF@>@VCOLJLROMFILQQOF>ILC12!5LOH@@LJMIFPEBAPB@QFLK 
.OBIFJFK>OVOBPRIQP&(%&%)()()$$%,*,$%+(%&$%$%(*(
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QEFPFPQEBCFOPQPBICJ>K>DBJBKQMOLDO>JCLO+1OBI>QBAPM>PQF@FQV>KAQEBCFOPQQLE>SB
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MBLMIBTFQE>AS>K@BA+1>KAMBLMIBTFQELQEBOKBROLILDF@>ILOLOQELMBAF@@LKAFQFLKP
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J>K>DBJBKQLC+1PM>PQF@FQV'JMLOQ>KQD>MPTBOBFABKQFCFBAJFKFJ>IBSFABK@B
BUFPQP?BVLKA?BIFBCQE>QOBDRI>OPQOBQ@EFKDOBAR@BPPM>PQF@FQVFJMOLSBPCRK@QFLK>I
JL?FIFQV>KAEBIMPQLMOBSBKQ@LJMIF@>QFLKPPR@E>P@LKQO>@QROBP>KA?BQQBO
JB>PROBPLCPM>PQF@FQV>OBKBBABAQL@>MQROBPM>PQF@FQVCOLJQEBM>QFBKQaPMBOPMB@QFSB
/RBPQFLKPBKALOPBAQLAOFSBCRQROBOBPB>O@E^"LBP>MOLDO>JLCA>FIVPQOBQ@EFKD
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MBOPMB@QFSB12!>PQ>KA>OAFWBAMOLDO>JCLOPM>PQF@FQVBAR@>QFLK>KAPQOBQ@EFKD
FKPQOR@QFLKKLTBUFPQPTFQEBSFABK@BLCCB>PF?FIFQV>KAFKFQF>IBCCF@>@VFK>J?RI>QLOV>ARIQP
TFQE+1>KAPM>PQF@FQVPBBPB@QFLKP?BILT2EB@LKCBOBK@BNRBPQFLKP>OBPQFII
OBIBS>KQ>KAFCCRKABAQEBMOLMLPBAPQRAVTFIIMOLSFABFKFQF>I>KPTBOP>KA%#&"**)
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.EVPF@>I2EBO>MVPPL@F>QFLKOBMOBPBKQ>QFSBLKQEB+1!LRK@FICLO!IFKF@>I.O>@QF@B

 
10 
 
 <Protocol version date:6/3/2021>  
 
Research Service Template: 9/9/15 
%RFABIFKBP1M>PQF@FQVT>P@ELPBK>P>KFJMLOQ>KQPVJMQLJARBQLQEBPBSBOFQV>KA
MOBS>IBK@BLCPM>PQF@FQVFK.T+1I>@HBSFABK@BCLOQOB>QJBKQTFQE@ROOBKQ>DBKQP>KA
QB@EKFNRBP>KAFK@LKPFPQBK@VLCQOB>QJBKQQEOLRDELRQQEBAFPB>PB@LROPB
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QLMF@P
• OB@LDKFWFKDPM>PQF@FQV
• NR>IFQVLCIFCB>KAQEBFJMLOQ>K@BLC?BE>SFLOP>KAQLLIPQLJ>FKQ>FK
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• OB@LDKFWFKDPM>PQF@FQVQOFDDBOP
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• QOB>QJBKQLCJFIAQLJLABO>QBPM>PQF@FQVTFQEJBAF@>QFLKPPQOBQ@EFKD>KALQEBO
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• >JBPP>DB>?LRQQEBFJMLOQ>K@BLCQ>HFKD@LKQOLILC+1PM>PQF@FQVCLOLSBO>II
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PBSBO>I>IQBOK>QFSBPMLPFQFLKP>OBMOLSFABACLOQEBPQOBQ@EBPTFQEQEBDL>ILCB>@EMBOPLK

 
11 
 
 <Protocol version date:6/3/2021>  
 
Research Service Template: 9/9/15 
CFKAFKD>QIB>PQLKBBUBO@FPBFKB>@EDOLRMQEBV@>KALOBDRI>OIVCLO>K>MMOLUFJ>QBIV
JFKRQBMBOA>VPQOBQ@EFKDOLRQFKB2EBBUBO@FPBP>OB
• `BILKD>QBaQEBTELIB?LAV>P>MOBM>O>QLOVOBI>U>QFLKBUBO@FPB
• QTL@ELF@BPB>@ECLOQORKHOLQ>QFLKFKKBOQEFDEPRMMBO@>ISBPILTBO@>ISBP>KA
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• BFDEQ@ELF@BPCLONR>AOF@BMP
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BUBO@FPBP>KA>PLMQFLKPCLOB>PFBOLOJLOB@E>IIBKDFKDPQOBQ@EBP2EBLMQFLKP>OBKLQ
ABPFDKBAQL?B>MOLDOBPPFLK>IQELRDEPLJB@LRIA?B@LKPFABOBAMOLDOBPPFLKPTFQE
MLPFQFLKPQE>Q>OBB>PFBOFKFQF>IIVCLOQFDEQJRP@IBP>KAQEBK@E>KDFKDQLLQEBOMLPFQFLKP
>PQEBJRP@IBP?B@LJBJLOBCIBUF?IB>KAQEBMBOPLKFPC>JFIF>OTFQEQEBBUBO@FPBP
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KLQBP>KAMBOPLK>IOBCIB@QFLKP>KAPQFIIMELQLPTFQETOFQQBKFKPQOR@QFLKPCLO>IIQEB
PQOBQ@EBPFK@IRABAFKQEBPB@LKA"4"
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PBSBO>IQFJBP>A>VHBBMPQEBJJLOB@LJCLOQ>?IB>KA>?IBQLJLSBJLOBCOBBIV1BQ

 
12 
 
 <Protocol version date:6/3/2021>  
 
Research Service Template: 9/9/15 
VLROMBOPLK>IPQOBQ@EFKDDL>I_2EB@I>PPPBPPFLKAFPMI>VP>MLPQBO>P>OBJFKABOTFQE
QEBCLIILTFKD^1QOBQ@EFKDPELRIA BALKBA>FIV,LQ?BM>FKCRI BEBIACLO>JFKFJRJ
LCQLPB@LKAP_1MB@FCF@>IIVMBOQEBOB@LJJBKA>QFLKPCLO>PQ>KA>OAFWBAMOLDO>J
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• (&**%$)>OB^>QIB>PQLK@BMBOA>V_QE>QFP>QIB>PQLKBOBMBQFQFLKLKBQFJBMBO
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@>OB1-!@LKQOLITFQEELJBMO>@QF@BRPFKD>KFIIRPQO>QBA?OL@EROBQEB,>QFLK>I+1
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13 
 
 <Protocol version date:6/3/2021>  
 
Research Service Template: 9/9/15 
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14 
 
 <Protocol version date:6/3/2021>  
 
Research Service Template: 9/9/15 

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15 
 
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16 
 
 <Protocol version date:6/3/2021>  
 
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17 
 
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18 
 
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19 
 
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20 
 
 <Protocol version date:6/3/2021>  
 
Research Service Template: 9/9/15 
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21 
 
 <Protocol version date:6/3/2021>  
 
Research Service Template: 9/9/15 
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22 
 
 <Protocol version date:6/3/2021>  
 
Research Service Template: 9/9/15 
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23 
 
 <Protocol version date:6/3/2021>  
 
Research Service Template: 9/9/15 
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29 
 
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33 
 
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34 
 
 <Protocol version date:6/3/2021>  
 
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35 
 
 <Protocol version date:6/3/2021>  
 
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37 
 
 <Protocol version date:6/3/2021>  
 
Research Service Template: 9/9/15 
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38 
 
 <Protocol version date:6/3/2021>  
 
Research Service Template: 9/9/15 
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39 
 
 <Protocol version date:6/3/2021>  
 
Research Service Template: 9/9/15 
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