Comparative trials on hybrid walking systems for people with paraplegia: An analysis of study methodology

References

• Altman D G. Statistics and ethics in medical research, in How large a sample?. Br Med J 15 November, 1980; 1336–1338
   Google Scholar
• Altman D G, Bland J M. Absence of evidence is not evidence of absence. Br Med J 19 August, 1995; 485
   Google Scholar
• Baardman G, Ijzerman M J, Leerdam N GA, VanHermens H J, Veltink P H, Boom H BK, Zilvold G. The SEPRLX: a separable reciprocator with intelligent knee stabilisation for people with paraplegia. Design and evaluation of a hybrid orthosis for people with paraplegia. PhD Thesis., University of Twente, Enschede 1997
   Google Scholar
• Bailey K R. Generalizing the results of randomised clinical trials. Contrall Clin Trials 1994; 15: 15–23
   PubMedGoogle Scholar
• Barnard G A. Must clinical trials be large? the interpretation of p-values and the combination of test results. Stat Med 1990; 9: 601–614
   PubMed Web of Science ®Google Scholar
• Beillot J, Carrè J, Le Claire G, Thoumie P, Perruoin-Verbe B, Cormerais A, Courtillon A, Tanguy E, Nadeau G, Rochcongar P, Dassonville J. Energy consumption of paraplegic locomotion using reciprocating gait orthosis. Eur J Appl Physiol 1996; 73: 376–381
   Google Scholar
• Borenstein M. The case for confidence intervals in controlled clinical trials. Controll Clin Trials 1994; 15: 411–428
   PubMedGoogle Scholar
• Bulpitt C J. Confidence intervals. Lancet 28 February, 1987; 494–497
   Google Scholar
• Carpenter L M. Is the study worth doing?. Lancet 24 July, 1993; 221–223
   Google Scholar
• Cook T D, Campbell D T. Quasi-experimentation: design and analysis issues for field settings. Houghton Mifflin, Boston 1979
   Google Scholar
• Dallal G E. PC-size: consultant - a program for sample size determinations. Am Stat 1990; 44: 243
   Google Scholar
• Davis C E. Generalizing from clinical trials. Controll Clin Trials 1994; 15: 11–14
   Google Scholar
• Dupont W D Pl, Ummer W D. Power and sample size calculations. A review and computer program. Controll Clin Trials 1990; 11: 116–128
   PubMedGoogle Scholar
• Edwards J, Bataweel A OP. Hybrid system for upright mobility with unlockable orthotic knee for knee bending during swing phase. Neuroprosthetics from basic research to clinical applications. Springer Veriag, Berlin 1996; 523–530
   Google Scholar
• Feinstein A R. Clinical epidemiology. The architecture of clinical research. W.B. Saunders, Philadelphia 1985
   Google Scholar
• Ferrarin M, Rabuffetti M. On the improvement provided by hip transversal rotation on paraplegic gait walking in reciprocating gait orthosis. In: biomedical and health research program (Bio Med) of the European Union. Neuroprosthetics from basic research to clinical applications, A Pedotti, M Ferrarin, J Quitren, R Reiner. Springer Veriag, Berlin 1996; 493–502
   Google Scholar
• Freeman P R. The role of p-values in analysing trial results. Stat Med 1993; 12: 1443–1452
   PubMed Web of Science ®Google Scholar
• Gallien P, Brissot R, Eyssette M, Tell L, Barat M, Wiart L, Petit H. Restoration of gait by functional electrical stimulation for spinal cord injured patients. Paraplegia 1995; 33: 660–664
   PubMedGoogle Scholar
• Gardner M J, Altman D G. Confidence intervals rather than p-values: estimation rather than hypothesis testing. Bri Med J March, 1986; 15: 746–750
   Google Scholar
• Hirokawa S, Grimm M, Le T, Solomonow M, Baratta R V, Shoji H, D'Ambrosia R D. Energy consumption in paraplegic ambulation using the reciprocating gait orthosis and electrical stimulation of the thigh muscles. Arch Phys Med Rehabil 1990; 71: 687–694
   PubMed Web of Science ®Google Scholar
• Isakov E, Douglas R, Berns P. Ambulation using the reciprocating gait orthosis and functional electrical stimulation. Paraplegia 1992; 30: 239–250
   PubMedGoogle Scholar
• Jefferson R J, Whittle M W. Performance of three walking orthoses for the paralysed: a case study using gait analysis. Prosthet Orthot Int 1990; 14: 103–110
   PubMed Web of Science ®Google Scholar
• Kleinsaum D G, Kupper L L, Muller K E. Applied regression analysis and other multivariable methods2nd edition. Duxbury Press, Belmont, California 1988
   Google Scholar
• Lachin J M. Introduction to sample size determination and power analysis for clinical trials. Controll Clin Trials 1981; 2: 93–113
   PubMedGoogle Scholar
• Lehman Stonebridge J. J. Knee lock device for knee ankle foot orthoses for spinal cord injured patients: an evaluation. Arch Phys Med Rehabil 1978; 59: 207–211
   Google Scholar
• Lotta S, Fiocchi A, Giovannini R, Silvestrin R, Tesio L, Raschi A, Macchia L, Chiapatti V, Zambelli M, Tosi C, Baratta S, Franceschini M. Restoration of gait with orthoses in thoracic paraplegia: a multicentric investigation. Paraplegia 1994; 32: 608–615
   PubMedGoogle Scholar
• McClelland M, Andrews B J, Patrick J H, Freeman P A, El Masri W S. Augmentation of the Oswestry parawalker orthosis by means of surface electrical stimulation: gait analysis of three patients. Paraplegia 1987; 25: 32–38
   PubMedGoogle Scholar
• Meinert C L. Clinical trials: design conduct and analysis. Oxford University Press, New York 1986
   Google Scholar
• Muszkat R, Yazbek P, Arango C T, Moreira M C, Trombetta I C, Battistella L R. Assessment of functional capacity during gait using a reciprocal propulsion orthosis (ARGO) - a comparative study with a conventional mechanical orthosis. Sao Paulo Med J 1994; 112: 495–499
   PubMedGoogle Scholar
• Nene A V, Patrick J H. Energy cost of paraplegic locomotion with the ORLAU parawalker. Paraplegia 1989; 27: 5–18
   PubMedGoogle Scholar
• Nene A V, Patrick J H. Energy cost of paraplegic locomotion using the parawalker-electrical stimulation “hybrid orthosis”. Arch Phys Med Rehabil 1990; 71: 116–120
   PubMedGoogle Scholar
• Nene A V, Jennings S J. Physiological cost index of paraplegic locomotion using the Orlau parawalker. Paraplegia 1992; 30: 246–252
   PubMedGoogle Scholar
• Ottenbacher K J. Why rehabilitation research does not work (as well as we think it should). Arch Phys Med Rehabil 1995; 76: 123–129
   PubMed Web of Science ®Google Scholar
• Ottenbacher K J, Barrett K A. Statistical conclusion validity of rehabilitation research. A quantitative analysis. Am J Phys Med Rehabil 1990; 69: 102–107
   PubMed Web of Science ®Google Scholar
• Petrofsky J S, Smith J B. Physiologic costs of computer-controlled walking in persons with paraplegia using a reciprocating gait orthosis. Arch Phys Med Rehabil 1991; 72: 890–896
   PubMed Web of Science ®Google Scholar
• Phillips C A. Electrical muscle stimulation in combination with a reciprocating gait orthosis for ambulation by paraplegics. J Biomed Eng 1989; 11: 338–344
   Google Scholar
• Pocock S J. Clinical trials, a practical approach. John Wiley, Chichester 1983
   Google Scholar
• Pollock C, Freemantle N, Sheldon T, Song F, Mason J M. Methodological difficulties in rehabilitation research. Clin Rehabil 1993; 7: 63–72
   Google Scholar
• Reilly R P, Findley T W. Research in physical medicine and rehabilitation. IV, Some practical designs in applied research. Am J Phys Med Rehabil 1989; 68: 196–201
   PubMed Web of Science ®Google Scholar
• Rothman K J. Modem epidemiology. Little Brown and Company, Boston 1986
   Google Scholar
• Sacks H S, Berrier J, Reitman D, Ancona-Berk V A, Chalmers T C. Meta-anatyses of randomized controlled trials. New Engl J Med 1987; 316: 450–455
   PubMed Web of Science ®Google Scholar
• Saitoh E, Suzuki T, Sonoda S, Fujitani J, Tomtta Y, Chino N. Clinical experience with a new hip-knee-ankle-foot orthotic system using a medial single hip joint for paraplegic standing and walking. Am J Phys Med Rehabil 1996; 75: 198–203
   PubMed Web of Science ®Google Scholar
• Salsburg D. Hypothesis versus significance testing for controlled clinical trials: a dialogue. Controll Clin Trials 1990; 9: 201–211
   Google Scholar
• Senn S. Cross-over trials in clinical research. John Wiley, Chicester 1993
   Google Scholar
• Smith W DF, Clark P F, Macarthur D, Allatt R D, Hayes K C, Cunningham D A. Oxygen cost using a reciprocating gait orthosis in a paraplegic (T9) patient with a bilateral below-knee amputation: case report. Spinal Cord 1997; 35: 121–123
   Google Scholar
• Smith A H, Bates M N. Confidence limit analyses should replace power calculations in the interpretation of epidemiologic studies. Epidemiology 1992; 3: 449–452
   PubMed Web of Science ®Google Scholar
• Stallard J, Major R E. The influence of orthosis stiffness on paraplegic ambulation and its implications for functional electrical stimulation walking systems. Prosthet Orthot Int 1995; 19: 108–114
   PubMed Web of Science ®Google Scholar
• Sykes L, Campbell I G, Powell E S, Ross E RS, Edwards J. Energy expenditure of walking for adult patients with spinal cord lesions using the reciprocating gait orthosis and functional electrical stimulation. Spinal Cord 1996; 34: 659–665
   Google Scholar
• Thoumie P, Perrouin-Verbe P, Le Claire G, Bedoiseau M, Busnel M, Cormerais A, Courtillon A, Mathe I f, Moutet F, Nadeau G, Tanguy E, Beillot J, Dassonvilue J, Bussel B. Restoration of functional gait in paraplegic patients with the RGO-II hybrid orthosis. A multicentric controlled study. I Clinical evaluation. Paraplegia 1995; 33: 647–653
   PubMedGoogle Scholar
• Wagenaar R C. Controlled single case experimental design: the rehabilition of stroke patients. Functional recovery after stroke. Free University, University Press, Amsterdam 1990
   Google Scholar
• Whittle M W, Cochrane G M. A comparative evaluation of the hip guidance orthosis (HGO) and the reciprocating gait orthosis (RGO). Health Equipment Information 1989; 192
   Google Scholar
• Winchester P K, Carollo J J, Parekh R N, Lutz L M, Aston J W, Jr. A comparison of paraplegic gait using two types of reciprocating gait orthoses. Prosthet Orthot Int 1993; 17: 101–106
   PubMed Web of Science ®Google Scholar
• Yang L, Granat M H, Paul J P, Condie D N, Rowley I. Further development of hybrid functional electrical stimulation orthoses. Spinal Cord 1996; 34: 611–614
   PubMedGoogle Scholar
• Yusuf S, Collins R, Peto R. Why do we need some large, simple randomised trials?. Stat Med 1994; 3: 409–420
   Google Scholar
• Dzerman M J, Baardman G, Hermens H J, Veltink P H, Boom H BK, Zilvold G. The influence of the reciprocal cable in the advanced reciprocating gait orthosis on paraplegic gait performance. Prosthet Onhot Int 1997a; 21: 52–61
   Google Scholar
• Ljzerman M J, Baardman G., Holweg G GJ, Hermens H J, Veltink P H, Boom H BK, Zilvold G. The influence of frontal alignment in the advanced reciprocating gait orthosis on energy cost and crutch force requirements during paraplegic gait. Basic Appl Myol 1997b; 7: 123–130
   Google Scholar